Hello Anon,
Indeed the questions being asked are quite broad and might want to seek some specific training or obtain expert support. Typically foreign establishment inspections by US FDA are notified 2 to 3 months in advance which is quite helpful in preparing and planning. Though note, the company needs to always be in a state of compliance and inspectional readiness, a notice of 2 to 3 months will not give any time for underlying or continuing issues a company may be experiencing. Those preparation time should be used to coordinate people's schedules, translation of documents, translators, logistics, etc.
An inspection of a foreign facility follows the same process as one done in the United States. There are some slight differences such as responding to any FDA Form 483 issued is done to a central location at FDA instead of the local district. Issuance of FDA Form 482 and Form 483 follow the same process. Responding to any Form 483 observations should be done in 15 days and again international submitting updates and potentially many documents can contact FDA for a way to upload large files or many documents as part of a response. There are resources needed to manage a FDA inspection properly so recommend not underestimating this process and seeking external support as needed.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 24-Apr-2024 10:49
From: Kevin Randall
Subject: Best practices and possible outcomes for FDA inspections
This is a very broad topic, and much can be said about it. But in a nutshell for purposes of this thread, my firm's training curriculum for our foreign clients highlights things like:
- Proactive early preparation and preplanning for a foreign FDA inspection
- FDA's legal authority
- FDA announcement and scheduling of foreign inspections
- FDA's standardized scope and duration for routine foreign inspections
- Inspectional approach
- Inspection management logistical best practices and considerations (e.g., how to answer and deal with FDA inspectors, documenting FDA's requests, answering these interrogations and providing evidence, controlling record movement and provision, front-room / back-room strategies, dealing with affidavits, and more)
- Form FDA 483 Inspectional Observations (used by FDA to officially record and notify the foreign firm about FDA's observations of objectionable conditions)
- The proper way to respond and resolve a Form FDA 483 (and the pitfalls to avoid) before the end of the inspection as well as, and especially, after the inspection
- How FDA deals with recidivism (repeated noncompliance) by way of Untitled Letters, Import Holds, Warning Letters, fines, seizures, injunctions and other FDA enforcement tactics
- Reminder that FDA's laws and regulations apply regardless of company size, though we are certainly allowed to adjust the complexity of our compliance activities commensurate with risk and complexity.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 24-Apr-2024 00:28
From: Anonymous Member
Subject: Best practices and possible outcomes for FDA inspections
This message was posted by a user wishing to remain anonymous
Can you please list possible outcomes for FDA foreign inspections at share best practices to handle the gaps or repeated noncompliance during and after the FDA foreign inspection? What is your experience and best practices for small medical device manufacturers companies with limited resources to solve such issues in best ways? Thank you!