Biomerieux, Inc. – FDA Warning Letter, Mar 6, 2012

On August 23, 2012, the FDA issued a Warning Letter to bioMerieux, Inc. following an inspection from January 24 to March 06, 2012, at their Durham, NC facility. The inspection revealed that the firm's in vitro diagnostic devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulations (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)):** This was evidenced by numerous non-conformances and recurring issues with BacT/ALERT production lots (e.g., low [b][4], faulty bottle seams, false positives), with inadequate or unverified corrective actions. 2. **Failure to adequately validate and document processes (21 CFR 820.75(a)):** Specifically, Line 1B BacT/ALERT validation activities were incomplete and lacked sufficient data. 3. **Failure to control non-conforming product (21 CFR 820.90(a)):** No documentation for rework of a large quantity of BacT/ALERT SN Lot 1030140 for [