FDA EIR - AMPAC Fine Chemicals Texas LLC - January 01, 2019

An FDA pre-approval inspection of AMPAC Fine Chemicals Texas, LLC, located in La Porte, TX, was conducted from January 15-17, 2019. The inspection, guided by C.P. 7346.832 and ICH Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients, aimed to assess the drug substance manufacturer's readiness for commercial production, conformance to application, and data integrity for new drug applications. The inspection identified several deficiencies, resulting in the issuance of an FDA Form 483. Key issues included inadequate documentation in batch records, specifically failing to record critical process parameters and allowing unquantified variances. The firm also did not ensure that all production deviations, such as alarms and alerts from their manufacturing control system, were properly reviewed or investigated. Laboratory controls were found lacking, with insufficient documentation and explanation for re-testing performed on samples, potentially indicating a failure to adhere to established procedures and investigate discrepancies. Furthermore, deviations from process parameters observed during validation lots were not formally documented. Beyond the 483 observations, the FDA investigator noted that the company’s recall procedure did not specify notifying the FDA within ten days, and its complaint procedure lacked specifics regarding adverse event reporting to the agency. Management acknowledged these findings and committed to implementing corrective actions for all identified issues. Voluntary corrections were initiated during the inspection, including reassessing equipment qualification and enhancing data integrity by restricting access to critical system parameters.