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Now in this article we are going to understand Understanding basic difference between Form 483 & Warning Letters.
Whistle-blowing:
The pharmaceutical industry is huge, Worldwide and more closer to home.
India is also one of the largest exporters of medicines to the United States. Medicines are highly regulated for expected reasons.
Over the last few years, corporate India has seen the rise of a new kind of crusader – the whistle-blower.
These champions have tried to uncover many scams related to Violation of laws, various data integrity issues & fraud activity.
Whistleblowing is a term that describes people who become aware of activities within an organization or entity that are legally questionable.
The FDA has believed that whistle blowing among employees & former employees is a critical way of maintaining compliance & corporate data integrity.
Whistle Blowers Types:
Internal Whistle Blower: The whistle blower has a connection to the organization. This could be an employee, an officer, or a shareholder.
External Whistle Blower: External whistle blowers reveal the activity to someone outside the company. That entity may be a law enforcement agency that has jurisdiction
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In the United States the False Claims Act encourages whistle-blowing by private individuals to expose evidence of fraud.
They are rewarded for their efforts with monetary compensation and protection from retaliation.
The FCA also contains an anti-retaliation provision which protects an employee from being “discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms & conditions of employment by his or her employer”
A former employee of a global pharma giant, received a $96-million settlement after suing her former employer under the False Claims Act (FCA).
Her initial whistle blowing case dealt with various data integrity issues as well dangerous slip ups such as product mix ups, missing validations & SOP’s in need of revision.
What was most shocking was that the company did not appeal & this became the first ever pharmaceutical whistle blowing lawsuit to invoke cGMP’s & succeed.
Reason of whistle-blowing
Failure to Comply with cGMPs Misrepresenting the safety & efficacy of drugs to federal regulators
Off-label Marketing: The law prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved.
Kickbacks: The law prohibits drug companies from offering or paying any remuneration, in cash or kind, directly or indirectly, to induce physicians or others to order or recommend drugs that may be paid for by a federal healthcare program.
Upcoding: Providers may not prescribe more of a drug than is medically necessary or for uses other than those approved by the FDA.
Ghost-Writing & Seeding Trials: companies draft medical papers promoting off-label uses of drugs & pay doctors to insert their names as authors of the documents
Overcharging federal healthcare programs for drugs
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To promote a zero tolerance approach towards malpractice,
Begin at grass roots level with the behavioral change of staff
Staff should be encouraged to report irregularities without fear
Staff should be trained in corporate policy & implementation.
Maintain proper internal control
Set effective communication between management & staff
Steps to a Successful Whistleblower Claim:
Contact a Pharmaceutical Whistleblower
Determine Whether A False Claim Exists
Don’t Talk to Anyone Except Your Lawyer
Gather Evidence Legally and Confidentially
Draft and File Your Whistleblower Claim
Assist with the Investigation
Prepare for Potential Retaliation
Have Check in Hand Before Spending the Money
Reviewing the legalities:
India
The Companies Act 2013 has made it mandatory for listed companies or such class of companies to establish vigil mechanisms for their directors and employees, in order to report genuine concerns in the recommended manner.
Clause 49 of the SEBI listing agreement also lays down similar provisions. Since drugs relate to patient safety, a sensitive subject, the CDSCO has devised a reward scheme for blowing the whistle on spurious or fake drugs.
USA
Under the Dodd-Frank Wall Street and the False Claims Act, an individual with knowledge of fraud committed by a business may blow the whistle to defined regulatory bodies.
If the claim is proven valid, the whistle-blower is entitled to a percentage, or “bounty”, of the sum recovered. Additionally, the Department of Justice (DoJ) has enforced CGMP violations under the False Claims Act.
Case Study
A bounty-ful reward An employee of a leading company blew the whistle on the company’s questionable manufacturing practices.
This was corroborated by providing evidence to the regulatory authorities on the company falsifying drug data and violating good manufacturing practices.
The investigation resulted in the drug maker pleading guilty to the wrongdoing and paying a hefty sum in settlement. The whistle-blower was awarded a significant sum from the regulator.
Does your organization have a whistle-blowing mechanism to report and investigate quality concerns, if any?
Did you know?
The CDSCO has implemented a reward scheme for individuals who report companies manufacturing fake or spurious drugs.
Association of Certified Fraud Examiners reports that whistle blowing is the most powerful method of identifying fraud in organizations.
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Now in this article we are going to understand Understanding basic difference between Form 483 & Warning Letters.
The Form 483 & FDA Warning Letter both serves a similar purpose to inform sponsors & principal investigators of issues requiring corrective action.
An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice. You need to respond in writing within 15 days of receiving both a 483 & a warning letter.
If you receive a warning letter, you’re required by law to make any changes necessary to satisfy the FDA’s concerns. A warning letter is far more serious than a 483 observation.
Any violations must be dealt with before you can meet compliance and bring your medical device tomarket.
What is FDA 483?
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) “Factory Inspection”.
Form FDA 483, “Inspectional Observations,” is a form used by the FDA to document & communicate concerns discovered during these inspections. Also referred to as “Form 483” or merely “483”, it states thereon that it
The FDA Form 483 is officially called a “Notice of Inspectional Observations,” commonly referred to simply as a “483.”
The 483 is issued at the end of an on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act.
Lists observations made by the FDA representative(s) during the inspection of your facility.
They are inspectional observations, and do not represent a final Agency determination regarding your compliance.
A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.
Responses should be comprehensive, well-reasoned, well-documented and timely, and that each observation should be addressed individually.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.
Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
Respond to the 483 or a Warning Letter promptly & identify your course of action to correct the findings within the FDA’s specified timeframe
The best way to minimize your chances of receiving a Form 483 is to always be “inspection ready.”
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You are obligated to respond to an FDA 483 observation in writing within 15 days.
Before an inspector leaves your facility, you’ll receive a draft of their inspection report (known as an Establishment Inspection Report, or EIR) as well as drafts of any 483 observations.
They’ll ask you whether you plan to address those observations, too
You should take time to review the Form 483 with the inspector once the inspection is finished. This is your opportunity to:
Gain an understanding of observations noted & assure their accuracy
Understand the broader message the agency is sending
Identify & discuss any errors in observations
Ask questions
Demonstrate awareness of applicable regulations
Consult with legal counsel as necessary
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An FDA warning letter is an official message from the United States Food & Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.
The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.
The FDA defines an FDA warning letter as:
“A correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.”
Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes.
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.
A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.
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Now in this article we are going to understand Do’s and Don’ts During FDA Inspection
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.
This List provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection.
To get your company started with proactive preparation (and avoid that call of panic), here is a list of dos and don’ts for being prepared.
Do’s:
• Answer all questions honestly;
• Say “I don’t know” or “I’ll get the answer for you;”
• Avoid such phrases as “I think,” “Sometimes/often/usually,” “never” and “next time;”
• Avoid qualifiers, such as “typically,” “normally,” “generally” and “usually;”
• Stop speaking once the question is answered;
• Ask for explanations or interpretations of what you do not understand;
• Maintain a friendly and cooperative attitude;
• Control your temper; remain courteous & professional
• Maintain eye contact.
Don’t:
• Volunteer information or answer a question that hasn’t been asked;
• Be sarcastic;
• Guess answers;
• Attempt to answer “what if?” or hypothetical questions;
• Argue with an investigator;
• Philosophize, ramble or editorialize;
• Point out deficiencies or errors;
• Apologize for problems or comments made by an investigator;
• Feel the need to respond to every comment made;
• Become defensive or evasive;
• Look away, fidget or look nervous
• Make statements about your personal opinion of the FDA.
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Now in this article we are going to understand Inspection Techniques that followed by Your Next Inspectors
What is QSIT?
QSIT provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer’s compliance with quality system regulations.
An FDA quality system inspection technique audit focuses primarily on four major subsystems and their respective documentation samples and is an efficient way to determine systemic weaknesses.
When an investigator conducts an FDA QSIT inspection, medical device companies can expect shorter audits and more serious repercussions—especially to upper management.
QSIT identifies the four major subsystems of the quality system:
Management Controls,
Design Controls,
Corrective and Preventive Actions (CAPA),
Production and Process Controls.
1 QSIT Management Controls
Inspectional Objectives:
1. Verify that a quality policy, management review and quality audit procedures, quality plan, and quality system procedures and instructions have been defined and documented.
2. Verify that a quality policy and objectives have been implemented.
3. Review the firm’s established organizational structure to confirm that it includes provisions for responsibilities, authorities and necessary resources.
4. Confirm that a management representative has been appointed. Evaluate the purview of the management representative.
5. Verify that management reviews, including a review of the suitability and effectiveness of the quality system, are being conducted.
6. Verify that quality audits, including re-audits of deficient matters, of the quality system are being conducted.
At the conclusion of the inspection….
7. Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.
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Note: If the project selected involves a device that contains software, consider reviewing the software’s validation while proceeding through the assessment of the firm’s design control system.
2. For the design project selected, verify that design control procedures that address the requirements of Section 820.30 of the regulation have been defined and documented.
3. Review the design plan for the selected project to understand the layout of the design and development activities including assigned responsibilities and interfaces.
Note: Evaluate the firm’s conduct of risk analysis while proceeding through the assessment of the firm’s Design Control system.
4. Confirm that design inputs were established.
5. Verify that the design outputs that are essential for the proper functioning of the device were identified.
6. Confirm that acceptance criteria were established prior to the performance of verification and validation activities.
7. Determine if design verification confirmed that design outputs met the design input requirements.
8. Confirm that design validation data show that the approved design met the predetermined user needs and intended uses.
9. Confirm that the completed design validation did not leave any unresolved discrepancies.
10. If the device contains software, confirm that the software was validated.
11. Confirm that risk analysis was performed.
12. Determine if design validation was accomplished using initial production devices or their equivalents.
13. Confirm that changes were controlled including validation or where appropriate verification.
14. Determine if design reviews were conducted.
15. Determine if the design was correctly transferred.
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1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
2. Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.
3. Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.
4. Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.
5. Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.
6. Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product.
7. Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.
8. Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.
9. Verify that corrective and preventive actions for product and quality problems were implemented and documented.
10. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.
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b. Use of the process for manufacturing higher risk devices;
c. Degree of risk of the process to cause device failures;
d. The firm’s lack of familiarity and experience with the process;
e. Use of the process in manufacturing multiple devices;
f. Variety in process technologies and Profile classes;
g. Processes not covered during previous inspections;
h. Any other appropriate criterion as dictated by the assignment
Note: If the process chosen is sterilization, evaluate the process according to the “Sterilization Process Controls” chapter of this handbook.
2. Review the specific procedure(s) for the manufacturing process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored.
Note: Control and monitoring procedures may include in-process and or finished device acceptance activities as well as environmental and contamination control measures.
3. If review of the Device History Records (including process control and monitoring records, etc.) reveals that the process is outside the firm’s tolerance for operating parameters and/or rejects or that product nonconformance’s exist:
a. Determine whether any nonconformance’s were handled appropriately;
b. Review the equipment adjustment, calibration and maintenance; and
c. Evaluate the validation study in full to determine whether the process has been adequately validated.
4. If the results of the process reviewed cannot be fully verified, confirm that the process was validated by reviewing the validation study.
5. If the process is software controlled, confirm that the software was validated.
6. Verify that personnel have been appropriately qualified to implement validated processes or appropriately trained to implement processes which yield results that can be fully verified.
Source: GUIDE TO INSPECTIONS OF QUALITY SYSTEMS GUIDE TO INSPECTIONS OF QUALITY SYSTEMS August 1999
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1 If FDA Issues a FORM 483, Prepare a Written Response:
During the exit interview, the FDA Investigators will likely present their observations, findings and conclusions. In most cases, any regulatory or food safety violations will be documented in an FDA FORM 483.
Although a response is not required by law, a company is generally expected to provide a written response within 15 business days. If the written response adequately addresses FDA’s concerns, FDA will not pursue further regulatory action.
If the response is inadequate, however, the agency may issue a “Warning Letter” threatening to withdraw the company’s registration and prevent it from producing product.
2 Form 483’s written response should include
The written response should include specifics:
Was the finding an oversight/one-time occurrence or systematic
What corrective actions will be taken and why the proposed response will correct the issue.
Provide a reasonable timeline for the correction
If the quality head is in disagreement with an observation, respond with facts and verifiable evidence.
Address each particular observation or finding, point by point.
The reply should be sent within two weeks.
Maintain a copy of the final signed responsein your office
If a 483 is issued, make a written response by including the specifics.
3 Support Your Written Response with Documentation:
When FDA issues a FORM 483 or “Warning Letter,” make sure your response is appropriately supported with adequate documentation.
For instance, FDA will not be satisfied if you simply state in your response that you corrected a problem that the FDA Investigators observed by “conducting additional employee training.”
Rather, in addition to stating that you completed the training, FDA will expect you to attach a training log or other document to your response which provides evidencing that the training was, in fact, completed.
4 If FDA Suggests a Recall, Consult Your FDA Counsel:
Sometimes the FDA Investigators will observe conditions they believe warrant a recall. The decision whether to announce a recall in the first instance, and any determinations regarding the scope of any such recall, can vary greatly depending upon the facts and data.
Any recall decisions should thus be made very carefully, and only after consultation with an experienced FDA compliance attorney.
Many companies have successfully convinced FDA, based upon the availability of supporting facts, forensic analysis and scientific data, that the agency is incorrect and a recall is not needed, or the scope can be significantly limited.
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11 Do Not Leave the FDA Investigators Unaccompanied:
Make sure that while the FDA Investigators are in your facility they remain accompanied. This way, the DI can observe and document the actions of the FDA Inspectors, and respond immediately to any concerns.
Additionally, if a company employee remains present at all times, the FDA Investigators will be less inclined to develop or discuss additional “unplanned” inspection “strategies” or “goals” with each other during the course of the inspection.
12 Do Not Sign Any Statements or Affidavits:
At the conclusion of the inspection, the FDA investigators may ask you or your employees to author or sign a statement or affidavit describing the inspection, the observations and/ or the conclusions.
Do not sign, correct or acknowledge any documents, as you have no legal obligation to do so.
If the inspector presents an affidavit for signature, politely decline to sign and tell the inspector that you must first consult with the FDA lawyer/ consultant
13 Exit Interview:
The FDA will usually hold an exit interview at the conclusion of the inspection. The escort, Principal Investigator, a representative from Institutional Compliance, and other individuals as appropriate should be notified of the time and place and expect to attend.
The inspector will discuss findings and notify the PI if deficiencies were found. This is an opportunity for the PI to provide information and clarify any questions or concerns raised during the inspection.
If serious deficiencies have been found during the inspection, a written Inspectional Observations (Form FDA 483) will be issued, which lists the deficiencies.
If no deficiencies are found, or the inspector has comments that s/he believes are not serious enough to warrant a Form FDA 483, no form will be issued.
During the exit interview: The Principal Investigator will seek to correct any errors in the findings
1. Both the FDA and Principal Investigator will make sure everything is clear and understood.
2. Observations, comments, and commitments will be noted in the escort inspection notes.
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6 Hold any Product from any Lines that FDA Samples:
In the event FDA collects any Zone 1 samples from any processing lines, be sure to hold the products that were produced during the periods that FDA was sampling until the FDA results come back.
Here too, if any results are positive, and the product has been held, a recall will not be necessary.
To provide additional protection, the company may also consider holding any product processed on equipment where Zone 2 samples were collected as well.
7 Aggressively Clean and Sanitize all Areas Sampled by FDA:
As soon as possible after FDA has completed its sampling, be sure to aggressively clean and sanitize each of the areas that the agency sampled.
This is because, in the event any sample is positive, you will be able to argue that whatever contamination existed at the time of sampling was eliminated and thus could not have affected any additional production.
8 Correct all FDA Observations Immediately:
During the course of the inspection, the FDA Investigators will likely share their findings and observations with the DI.
Wherever possible, make sure to immediately correct to the satisfaction of the FDA Investigators any observations that are critical of the company.
Doing so will demonstrate that the company is committed to quickly resolving any concerns, and the FDA Investigators may choose not to record those observations in the final FDA Form 483.
9 Know What Records FDA is permitted to Review:
FDA has very broad powers to access records. Generally speaking, FDA will be able to review a company’s written food safety programs and related records.
The agency is not entitled, however, to review or copy any recipes, financial data, pricing data, personal data (other than to ensure that the company’s employees have received training appropriate to their position and responsibilities), research data, and sales data (other than shipment information).
10 Protect the Confidentiality of any Records FDA Copies:
If FDA requests copies of any records the company deems confidential, be sure to mark those records with the following statement:
THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN CONSTITUTES TRADE SECRET, CONFIDENTIAL AND PROPRIETARY COMMERCIAL INFORMATION PURSUANT TO 5 U.S.C. 552(b)(4), AND SHALL BE STRICTLY PROTECTED AS SUCH FROM ANY DISSEMINATION AND/OR DISCLOSURE.
This will put the agency on notice that the information must be protected and may not be disseminated publicly.
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Ensure that ALL members of the research team know that the FDA is in the facility. Inform other staff when you will be giving the inspector a tour of the facility.
The escort will walk the inspector to an appropriate meeting room. The inspector will present his/ her credentials to verify that they are in order; do not expect the investigator to permit a copy to be made of his/her badge/credentials.
The designated escort should stay with the inspector at all times
The inspector will then present a Notice of Inspection (482) to the Principal Investigator, this notice authorizes the inspection and its presentation officially begins the inspection.
The inspector will explain the intended purpose and scope of the inspection, then ask the PI to summarize the study.
2 Opening Meeting
The inspector should present his/her credentials to the PI to verify that they are in order.
Ask the inspector to see his/her credentials if he/she does not present them.
Document all information from the inspector’s identification as no copies of the identification badges can be made.
The inspector will present a Notice of Inspection (Form FDA 482) to the PI authorizing the inspection.
This presentation officially begins the inspection.
The inspector will explain the intended purpose and scope of the inspection.
If the team does not ask for the inspector’s credentials and/or the Form 482, the inspector may note this as a deficiency in his/her report.
The inspector will ask the PI to summarize and discuss the study identified for inspection and his/her responsibilities with respect to the study.
The inspector may ask the PI for the list of his/her studies.
3 Attempt to Negotiate the Areas Being Sampled:
During the entrance meeting, the FDA Investigators will typically disclose the types of ingredients, products and/or environmental areas they intend to sample.
Attempt to negotiate with the agency to limit the amounts, types or overall focus of the sampling in such a way that, if any results are positive, you can limit to the greatest extent possible the scope of any recall.
4 Escort’s Role & Responsibility:
The escort’s role is to coordinate all FDA requests and see that the inspector’s questions are answered honestly and completely. Listen to the question; answer the question that was asked.
Defer to others if you don’t know; when possible use documents already provided for support of answers. Stop when the question is fully answered.
There is nothing wrong with silence: when you have answered, wait for the next questions.
How to answer FDA Questions:
Be concise; answer only the question that is asked.
Always be clear with the answers to questions.
Be positive and confident.
Take corrective actions if possible, commit only to what you can deliver.
DO NOT volunteer information. DO NOT guess or speculate
DO NOT lie. DO NOT argue.
DO NOT panic.
DO NOT sign affidavits.
5 Carefully Document the Areas Being Sampled by FDA:
While the FDA Investigators are conducting their sampling, be sure to carefully document the exact areas from which the FDA Investigators are collecting their samples.
In addition, be sure to appropriately characterize the areas being sampled by the agency as Zone 1, Zone 2, Zone 3, or Zone 4.
This information will be critical in the event that any samples are positive to determine the most appropriate response.
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Long before your next FDA inspection, you should add an FDA lawyer familiar with the inspection process to the company’s emergency contact list who can be notified and remain “on call” once the inspection begins.
This person can serve as a useful resource to help quickly answer any difficult regulatory or investigator-related questions that arise during the inspection.
17 Conduct a Mock FDA Inspection:
One of the best ways to prepare for a visit from FDA is to conduct a mock inspection. FDA consultants and/or lawyers can visit your facility and play the role of the FDA Investigator.
Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.
18 Building and Facilities. Check whether
Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.
Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.
Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.
Lighting and ventilation are sufficient for the intended operation and comfort of personnel.
Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.
19 Equipment. Check whether:
Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.
Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.
Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.
20 Personnel. Check whether:
The personnel supervising or performing the activity or control of cosmetics has the proper education, training and/or experience to perform the assigned functions.
Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.
Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.
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