FDA WARNING_LETTER - Greiner Bio One Brasil Medical Hospital Products Ltda. - January 16, 2014

On August 8, 2014, the FDA issued a Warning Letter to Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. following an inspection from January 13-16, 2014. The inspection revealed that the firm's Vacuette blood collection tubes, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain procedures for design changes (21 CFR 820.30(i))**: A labeling change (#25/2013) for Vacuette Erythrocyte Sedimentation Rate Tubes lacked formal procedures for change activities, verification, and documentation. The firm's response was inadequate, failing to provide evidence of implemented corrections, systemic corrective actions, or employee training. 2. **Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g))**: The firm did not perform ongoing testing for shelf-life stability or maximum trace element content for Vacuette collection tubes as required by product labeling. The response was inadequate, lacking evidence of implemented corrections, systemic corrective actions, or employee training. 3. **Failure to establish and maintain procedures for acceptance of incoming product (21 CFR