Jilin Shulan Synthetic Pharmaceutical Co. Ltd. – FDA Warning Letter, Aug 28, 2009

The FDA issued a Warning Letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. on May 13, 2010, following an August 24-28, 2009 inspection of their API manufacturing facility in China. The inspection revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's October 12, 2009, response was deemed insufficient.

Key violations included: 1. **Production Deviations:** Failure to report, evaluate, and investigate critical production deviations, such as out-of-range equipment parameters and inadequate shift changeovers. 2. **Master Production Records:** Incomplete master production records lacking critical manufacturing steps (e.g., (b)(4) stage) and inaccurate batch production records. Concerns were raised about the quality of recovered (b)(4). 3. **Facility Design and Maintenance:** Buildings and facilities were not designed to facilitate cleaning and minimize contamination, with issues like peeling tape, accumulated debris, rusty equipment, and improper cleaning procedures. Uncovered in-process materials and improperly closing doors were also observed. 4. **Quality Unit Failures:** Failure to reject APIs contaminated with foreign material (e.g., glass from a broken light, "black spots"), and performing maintenance during production. 5.