Gibson Laboratories Inc – FDA Warning Letter, Sep 14, 2009

On August 19-September 14, 2009, an FDA inspection of Gibson Laboratories, LLC in Lexington, KY, identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their in vitro diagnostics and agars, classifying their devices as adulterated under section 501(h) of the Act.

Key violations include: 1. **Process Validation (21 CFR § 820.75(a)):** Failure to adequately validate sterilization processes for medical devices (media) and equipment. Issues included lack of justification for product loads and temperature probes during validation, and discrepancies between validation and actual sterilization times. 2. **Product Handling (21 CFR § 820.140):** Failure to ensure product integrity during shipping. Products labeled for 2°C to 8°C storage were not shipped under refrigerated conditions, with no documented justification. 3. **Nonconforming Product (21 CFR § 820.100(a)(2) and (3)):** Inadequate investigation of nonconforming products (e.g., contamination). Corrective actions, like retraining, were ineffective, as evidenced by recurring contamination complaints and rejected lots. Failure investigations did not include reviewing environmental testing results or identifying root causes. 4. **Corrective and Preventive Action Documentation (21 CFR § 82