FDA 483 - ALI Pharmaceutical Manufacturing LLC - October 03, 2022

During an inspection conducted from September 26 to October 3, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to ALI Pharmaceutical Manufacturing, LLC, a drug substance manufacturer located in Omaha, NE. The inspection identified significant deviations from regulatory expectations, primarily concerning quality control and manufacturing processes.Key observations included the failure to establish scientifically validated procedures for monitoring and controlling processing steps, particularly those related to reducing microbial contamination in intermediate materials. The company also lacked scientifically sound specifications, sampling plans, and test procedures for both in-process materials and finished drug substances, including a notable absence of total yeast and mold testing and inadequate microbial specifications.Furthermore, ALI Pharmaceutical Manufacturing, LLC was cited for not properly investigating critical deviations or out-of-specification results. Numerous product failures lacked identified root causes, comprehensive corrective actions, or an assessment of potential impact on other batches. The quality unit's responsibilities were also found to be inadequately defined and followed, with issues such as insufficient stability testing programs, unvalidated intermediate hold times, and deficiencies in cleaning validation. The company is expected to thoroughly address these observations, demonstrating comprehensive corrective and preventive actions to ensure compliance with drug manufacturing regulations and safeguard product quality and safety.