Nanjing Pharmaceutical Factory Company Limited – FDA Warning Letter, Sep 25, 2009

This FDA Warning Letter, dated September 21-25, 2009, addresses Nanjing Pharmaceutical Factory Company Limited for significant deviations from cGMPs in manufacturing Active Pharmaceutical Ingredients (APIs) Praziquantel (animal drug) and Sucralfate (human drug). The inspection revealed adulterated APIs under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Quality Unit Failures:** Pervasive data alteration (scraping/erasing original data) in 80% of reviewed batch records, lack of investigation into these practices, and failure to ensure effective calibration/maintenance systems for critical equipment (HPLC, GC, balances, thermometers) with missing or unapproved procedures and data. The Quality Control Unit (QCU) also failed to review and approve blank production batch records. 2. **Documentation Deficiencies:** Operators not recording their own observations; entries made by a "GMP Controller" inconsistent with procedures. 3. **Inadequate Stability Program:** No approved stability protocols for Praziquantel and Sucralfate, and stability samples not stored under controlled conditions (unsealed room, no continuous temperature/humidity recording). 4. **Personnel Qualification:** Incomplete training records for operators, lacking specific SOPs trained on, and inadequate training for temporary employees. 5. **Analytical Equipment Validation:** Electronic formulas for assay, related compounds, and residual solvents