FDA EIR - Patheon API Services Inc. - August 28, 2015

An FDA routine surveillance inspection of Patheon API Services in Florence, SC, was conducted from August 24-28, 2015, focusing on Active Pharmaceutical Ingredient (API) manufacturing processes under Compliance Program 7356.002F. The inspection identified several significant deficiencies, resulting in the issuance of a Form FDA 483, Inspectional Observations.Main violations included insufficient or unadhered-to quality control unit procedures for detecting, evaluating, and correcting deviations. Specifically, the Corrective and Preventive Action (CAPA) procedure lacked provisions for verifying the implementation and effectiveness of actions. Deviation investigations were often not documented at the time of occurrence, and approximately 23% in 2014 exceeded the 30-day closure timeframe without justification. Product Quality Investigations also frequently missed their 30-day closure targets. Additionally, the material sampling and finished goods inventory control procedures were not followed, evidenced by uninvestigated reconciliation discrepancies in sample labels, such as a 0.101 kg weight discrepancy for a product lot.Furthermore, written production and process control procedures were deemed inadequate and not followed. This included the lack of secondary operator initials and/or dates for solution preparation calculations in pilot plant logbooks, impacting roughly 1,200 pages of entries. The solutions logbook procedure also lacked sufficient detail on how secondary operators should verify information, leading to instances where incorrect calculations were approved.Patheon API Services management committed to submitting a written response to the FDA 483 within 15 business days, outlining their corrective and preventive actions to address these observations.