FDA EIR - Almac Clinical Services, LLC - December 22, 2017

An FDA Pre-Approval and comprehensive cGMP inspection of Almac Clinical Services, LLC in Souderton, PA, was conducted from December 19-22, 2017. The inspection, guided by FDA Compliance Programs 7356.002 and 7346.832, focused on commercial manufacturing readiness, application conformance, and data integrity. A single observation was issued on Form FDA-483 for failure to fully follow procedures, specifically related to the responsibilities of the quality control unit (21 CFR 211.22(d)). The main violation involved numerous Standard Operating Procedures (SOPs) that were significantly overdue for review, some dating back to 2015, without proper quality event initiation. Additional issues discussed included vague procedures, lack of adequate sample tracking and chain of custody, and deficiencies in method transfer testing, such as the omission of Limit of Detection evaluation and concerns regarding impurity specificity. Management committed to addressing the overdue SOPs and indicated plans to implement a computer-based sample tracking system. Almac Clinical Services, LLC was required to submit a written response to the deficiencies noted.