Bio-Rad Laboratories GmbH – FDA Warning Letter, Jan 22, 2015

On September 3, 2015, the FDA issued a Warning Letter to Bio-Rad Laboratories GmbH following an inspection from January 19-22, 2015, which found their Hemoglobin Capillary Collection Systems (HCCS), ALA/PBG kits, and Porphyrin kits to be adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Procedures lacked requirements for verifying/validating actions and analyzing nonconformity sources using statistical methodologies. CAPA forms were not completed as required, and effectiveness of actions was not tracked. The firm's response was inadequate as it didn't confirm corrections for specific NCRs or provide a rationale for a limited retrospective review timeframe. 2. **Failure to maintain complaint investigation records (21 CFR 820.198(e))**: An International Customer Complaint Report (ICCR) lacked documented investigation elements, including QC release testing, investigation dates, corrective actions, and responses to complainants. The firm's response was inadequate, failing to correct specific complaint documentation errors or justify the retrospective review timeframe. 3. **Failure to establish and maintain device design validation procedures (21 CFR