Sichuan Friendly Pharmaceutical Co., Ltd. – FDA Warning Letter, Oct 27, 2017

The FDA issued a Warning Letter to Sichuan Friendly Pharmaceutical Co., Ltd. following an inspection from October 23-27, 2017, identifying significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to conduct residual solvent testing:** The firm did not test for residual solvents (e.g., (b)(4)) in their (b)(4) USP API, despite using shared equipment and Class 2 solvents. Required actions include a comprehensive risk assessment, retention sample test results, and a plan for out-of-specification batches. 2. **Inadequate cleaning validation:** Cleaning procedures for non-dedicated equipment were not validated to prevent cross-contamination. The firm's validation was insufficient, only using one challenge product on a limited number of equipment pieces and not addressing residual solvent carryover. The FDA requires updated cleaning validation for all multi-use equipment and a comprehensive risk assessment. 3. **Insufficient stability testing program:** The firm lacked data to support the (b)(4) shelf-life of their (b)(4) API and did not use stability-indicating methods. The FDA demands an updated stability program and retention sample test data using appropriate methods. 4. **Inadequate controls over computerized systems:** A non-validated Excel spreadsheet with incorrect, unlocked formulas was used for assay calculations, leading to inaccurate Certificates of Analysis and out-