Biotech International – FDA Warning Letter, Jun 3, 2010

On October 1, 2010, the FDA issued a Warning Letter to Biotech International following an inspection from May 31 to June 3, 2010, at their Salon de Provence, France facility. The inspection found that the firm's Cross.Bone bone void filler device and Omnitech and Easylock Osteosystem bone fixation plates are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820). The firm's responses were not reviewed as they were not received within 15 days.

Key violations include: 1. Failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a)), lacking requirements for analyzing quality data sources and verifying/validating actions. 2. Failure to document corrective and preventive action activities and results (21 CFR 820.100(b)), with examples of missing investigation, proposed actions, and validation for nonconforming reports. 3. Failure to control nonconforming product (21 CFR 820.90(a)), as returned nonconforming devices were not identified as such and were improperly labeled. 4. Failure to validate computer software