FDA EIR - Cheng Fong Chemical Co., Ltd. Dayuan Factory - April 22, 2016

An FDA Good Manufacturing Practice (GMP) Surveillance inspection of Cheng Fong Chemical Co. Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Taoyuan City, Taiwan, was conducted from April 18-22, 2016. The inspection, performed under Compliance Policy Guidance Manual (CPGM) and ICH 7 guidelines for APIs used in human and veterinary drugs, aimed to assess the firm's compliance. While previous inspection deficiencies from 2013 regarding quality unit procedures, validation, and analytical methods were reportedly corrected, the current assessment revealed ten new significant observations. Key violations cited in the FDA 483 form included inadequate laboratory controls, incomplete data in laboratory records, and a critical lack of Quality Unit oversight on analytical testing. The firm failed to properly investigate and document critical deviations, consumer complaints, and changes to processes, equipment, and procedures, with Out-of-Specification (OOS) and critical incident investigations being incomplete. There was also an absence of second-person verification for raw analytical data. Furthermore, facility-related issues involved unvalidated cleaning procedures for API production equipment, poor maintenance of buildings impacting product quality, and improper storage of materials in unsanitary cold rooms. The firm also lacked appropriate procedures for calibrating and testing water used in production and laboratories. Cheng Fong Chemical Co. Ltd. was required to submit a written response to the FDA within fifteen business days, detailing their corrective actions for these observations.