FDA WARNING_LETTER - Novacyl Wuxi Pharmaceutical Co., Ltd. - October 18, 2013

On December 19, 2014, the FDA issued a Warning Letter to Novacyl Wuxi Pharmaceutical Co. Ltd. following an inspection from October 14-18, 2013. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs) and violations of CGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211), rendering their products adulterated.

Key violations include: 1. **API CGMP Deviation:** Failure to manage laboratory systems with sufficient controls, leading to missing raw data, undocumented changes to integration parameters, lack of procedures for manual integration, shared passwords, and use of uncontrolled worksheets and chromatograms. An example cited was a discarded chromatogram showing an additional peak for an API. The firm's previous corrective actions were deemed insufficient. 2. **Finished Product CGMP Violations:** * Failure to properly document or investigate out-of-specification (OOS) results and other discrepancies (21 CFR 211.192), such as an OOS investigation for metal particles in a product that lacked root cause determination. * Failure to establish adequate laboratory controls, including scientifically sound specifications and test procedures (21 CFR 211.160(b)). * Failure to record all CGMP activities contemporaneously (21 CFR 211