I have published articles that made compliance professionals uncomfortable. Articles that named what most publications in this space are too cautious to name. Articles that generated more direct replies than anything else I have written.
This one is different.
What you are about to read is the most controversial conversation ever published in The Investigator’s Lens. Four former FDA Investigators, combined 71 years of field experience, sitting in a room and saying out loud what most people in this industry will only say in private.
The topic: why pharmaceutical companies keep getting away with repeat violations. Not the official answer. The real one.
What Makes This Conversation Different
Most discussions of FDA enforcement stay safely in the abstract. Resource constraints. Regulatory complexity. The inherent difficulty of inspecting a global supply chain with a finite workforce.
This conversation does not stay in the abstract.
One participant is a former Investigator now sitting as a VP of Quality inside a major pharmaceutical manufacturer. He described, on the record, how resource allocation decisions are actually made inside large pharmaceutical organizations when a 483 observation does not affect a high-priority product. People in his position do not say this publicly. He said it.
One participant is a PhD microbiologist with 18 years of FDA field experience who now consults on sterility assurance and contamination control. She named the specific operational decisions that create repeat contamination control failures. Not in the abstract.
One participant is a registered nurse who spent 17 years conducting FDA inspections including clinical trial site inspections. She described sitting with patients in clinical trials who experienced serious adverse events in programs where the sponsor had been cited for similar failures in a prior trial. She is the voice in this conversation that will not let the discussion stay comfortable.
And there is me. 14 years as an FDA Investigator. 13 years as a Quality executive on the industry side. 6 years auditing from the outside. I have seen this problem from every angle and I moderated this conversation because I believed it needed to exist.
We talked about the enforcement tools FDA has and is
not using. We talked about what happens inside organizations when
the connection between a CAPA response and the patient
at the end of the supply chain gets lost. And we talked about what breaks the cycle.
Read the full roundtable here: https://open.substack.com/pub/devaughnedwards/p/the-roundtable-pharmaceutical-companies?r=7sflcx&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true
DeVaughn Edwards is a former FDA Investigator with 14 years of field experience, a pharmaceutical quality executive with 13 years of hands-on compliance leadership, and the founder of FD-AID LLC. He conducts mock FDA inspections and inspection readiness engagements for pharmaceutical manufacturers, CDMOs, and biologics facilities.
Contact: devaughn@fdaid.org | fdaid.org | 732-895-7831
FD-AID | FDA Inspection Readiness | Former FDA Investigator 