Biomedica Diagnostics Inc – FDA Warning Letter, Jun 2, 2011

On October 17, 2011, the FDA issued a Warning Letter to BioMedica Diagnostics, Inc. following an inspection from May 30 to June 2, 2011. The inspection revealed that the firm's plasma and coagulation control products, 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) CGMP requirements.

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: Underlying causes of non-conformities (e.g., wrong cap threads, incorrect Certificates of Analysis, conflicting expiry dates, non-conforming manuals) were not investigated, and preventive actions were not documented. 2. **Inadequate equipment requirements (21 CFR 820.70(g))**: A specific piece of equipment used in manufacturing was not demonstrated to operate consistently at specified parameters. 3. **Failure to establish statistical techniques (21 CFR 820.250(a))**: Sampling plans for acceptance activities lacked valid statistical rationale, and the number of units sampled was not documented for various components and raw materials. 4. **Inadequate complaint handling (21 CFR 820.198(