Latest FDA Enforcement Hot-Spots and Targets: The View from the Trenches

Q: I’m a Quality Auditor and looking for information on the latest FDA enforcement focus. From your perspective as an ex-FDA investigator who now helps industry avoid trouble, what is FDA enforcement “going after” these days?

A: Supplier management — how carefully manufacturers manage and control their suppliers — remains an FDA focus and likely will continue in the coming years.

FDA is seeing far too many companies where management support, oversight, and involvement in the Quality System is lacking.

Executive management, management responsibility, and Quality System management are also key areas. FDA is seeing far too many companies where management support, oversight, and involvement in the Quality System is lacking.

We’ve seen an up-tick in CAPA and Medical Device Reporting (MDR) issues for some companies. FDA has begun to recognize that “tools and instruments” used for installing medical devices are problematic and have led to a number of recalls.

Problems related to poor Design Control are appearing more and more frequently in FDA Warning Letters issued to medical device companies.

Last, but certainly not least, system and software validation (or the lack thereof) and data integrity problems are a major FDA enforcement focus, especially internationally.

That’s why you’ve seen FDA’s new Data Integrity and Compliance with cGMP Guidance — which doesn’t really cover much new ground but reinforces what the Agency has been saying for years — and a substantial number of Warning Letters and even import alerts concerning drug-makers in India, China, and elsewhere.

Answered by Martin Browning, President and Co-Founder of EduQuest, who served 22 years at the U.S. FDA as an expert field investigator and who also co-wrote 21 CFR Part 11 and contributed to the Quality System Regulation (21 CFR Part 820). Martin is the chairman of EduQuest’s FDA Auditing of Computer Systems and Part 11/Annex 11 Compliance training class. He also is the principal speaker for EduQuest’s 4-Hour Executive Briefing on Management Responsibility for Quality Systems.

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