FDA EIR - Cheng Fong Chemical Co., Ltd. Dayuan Factory - March 09, 2018

An FDA inspection of Cheng Fong Chemical Co., Ltd. was conducted from March 5-9, 2018, as a follow-up to a previous inspection and a 2016 Warning Letter. The inspection evaluated the Taiwan-based active pharmaceutical ingredient manufacturer's compliance with Good Manufacturing Practices, specifically CPGM 7346.002F and ICH Q7A guidelines. The primary concerns noted in the FDA-483 form issued to the company revolved around significant deficiencies in the Quality Unit's oversight and documentation practices. These included a failure to thoroughly review and verify production and release documents, leading to approval of records with inaccurate manufacturing parameters and release of products despite uninvestigated out-of-specification results. Employee training on critical procedures, such as handling out-of-specification results and accurate sample preparation, was also found to be inadequate. While some prior equipment cleaning issues were rectified, two granulators continued to show dent marks on product-contact surfaces, indicating persistent maintenance challenges. Past laboratory control issues, such as incomplete test data and lack of solution stability studies, had largely been addressed, but some concerns regarding analytical procedures remained. Cheng Fong Chemical Co., Ltd. was instructed to provide a written response to these observations within fifteen working days, outlining corrective actions to ensure compliance and prevent further regulatory action.