Biotek India – FDA Warning Letter, May 25, 2021

The FDA issued a Warning Letter to Biotek India, an OTC drug manufacturer, following a review of submitted records. The facility's drug products are deemed adulterated due to significant CGMP violations.

Key violations include: 1. **Failure to test finished drug products (21 CFR 211.165(a)):** Biotek India distributed products, including isopropyl rubbing alcohol, without adequate testing for identity and strength of active ingredients. The FDA requires a list of specifications, an action plan for testing retain samples of all in-expiry batches, and a summary of results, with rapid corrective actions for substandard products. A comprehensive, independent assessment of laboratory practices and a remediation plan are also required. 2. **Failure to test raw materials (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming raw materials for identity. The FDA requires an independent review of the material system, chemical and microbiological specifications for incoming components, a description of how each component lot will be tested, and a summary of results from testing components to validate supplier COAs. 3. **Failure to establish an adequate stability testing program (21 CFR 211.166(a)):** Biotek India lacked sufficient stability data, particularly for active ingredient and microbiological stability, to support labeled expiry dates. The FDA requires a comprehensive, independent assessment and CAPA plan for the stability program, including stability-