Author Archives: Innovative Appz

In Earlier post we understood Understanding basic difference between Form 483 & Warning Letters in Pharma Industry? 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 UnitedContinue reading “What is Whistle-blowing? It will save you or your Company or Public?”

In Earlier post we understood Tips for Setting up Your Team for Inspection. in Pharma Industry? 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 FDAContinue reading “Understanding basic difference between Form 483 & Warning Letters”

In Earlier post we understood Do’s and Don’ts During FDA Inspection in Pharma Industry? Now in this article we are going to understand Tips for Setting up Your Team for Inspection. Tips is designed and built to empower teams Inspectors Team: Consists of one lead inspector & assisting inspector(s). Where appropriate, one or more technical specialists may be included.Continue reading “Tips for Setting up Your Team for Inspection”

In Earlier post we understood Inspection Techniques that followed by Your Next Inspectors in Pharma Industry? 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 providesContinue reading “Do’s and Don’ts During FDA Inspection”

In Earlier post we understood Checklist that will helpful in your next Inspection in Pharma Industry? 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 systemContinue reading “You must know Inspection Techniques that followed by Your Next Inspectors”

Checklist that will helpful in Post Inspection 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 notContinue reading “Checklist that will helpful in your next Inspection Part IX”

Checklist that will helpful in During Inspection 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 remainsContinue reading “Checklist that will helpful in your next Inspection Part VIII”

Checklist that will helpful in During Inspection 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, ifContinue reading “Checklist that will helpful in your next Inspection Part VII”

Checklist that will helpful in During Inspection 1 Arrival of Inspector 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 inspectorContinue reading “Checklist that will helpful in your next Inspection Part VI”

Checklist that will helpful in Before Inspection 16 Identify an Appropriate “On Call” FDA Lawyer:  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 asContinue reading “Checklist that will helpful in your next Inspection Part V”