During a recent FDA inspection, the CEO of a pharmaceutical firm voluntarily stated that the company “has not conducted raw material identity testing on incoming APIs and components.” This admission, unprompted and likely unintended, became a focal point of a damning 483 observation, offering a pertinent example of what not to do when FDA arrives at your door.
“Your firm relies on the Supplier’s Certificate of Analysis for incoming APIs and components without performing identity testing. Moreover, during the inspection, your firm’s CEO stated the firm has not conducted raw material identity testing on incoming APIs and components used as an ingredient in [product].”
This single statement confirmed a clear violation of 21 CFR §211.84(d)(1), which mandates that each component be tested for identity upon receipt, regardless of supplier-provided documentation. In most cases, this regulation is well understood by Quality Units, and many firms are careful to avoid affirming such noncompliance explicitly. But here, the CEO himself removed any doubt and handed FDA a noncompliance admission outright.
The following is a non-exhaustive list of best practices for managing FDA inspections:
- Limit participation to trained personnel: Only individuals trained in FDA inspection protocol and deeply familiar with the applicable quality systems should speak.
- Use an inspection response team: Designate a core team, including a scribe, guide, and technical SME, to manage the inspection flow.
- Prepare executives for roles behind the scenes: Keep leadership informed, engaged, and resourced, but out of the room unless absolutely necessary.
- Practice mock inspections: Include simulation of unexpected questions to avoid panic responses or damaging improvisation.
This firm’s CEO likely believed he was being forthright. Instead, he confirmed a violation that might otherwise have been mitigated, clarified, or at least contextualized by the Quality Unit.
