Catalent Indiana, LLC – FDA EIR, Jan 19, 2018

An FDA pre-approval inspection was conducted at Cook Pharmica, LLC in Bloomington, IN, from January 16-19, 2018. This inspection was performed on behalf of the European Medicines Agency (EMA) under a mutual reliance agreement, focusing on the company's role as a contract manufacturer of parenteral/sterile finished pharmaceuticals, medical devices, and therapeutic protein drug substances. The regulatory framework encompassed compliance program 7356.002F for Active Pharmaceutical Ingredient (API) Process Inspection, involving a review of Quality, Materials, Production, and Laboratory systems. The current inspection resulted in a single FDA Form 483 observation regarding the firm's failure to properly follow material reconciliation procedures for its working cell bank. This highlighted a deviation from established written protocols for component storage in drug substance manufacturing. A previous inspection in May 2017 had identified multiple deficiencies, including unwritten or unfollowed quality unit responsibilities, production procedures not being followed or documented, and issues with medical device manufacturing processes such as undocumented testing, unimplemented media fill and supplier control procedures, and an inadequate corrective and preventive action (CAPA) system. Management at Cook Pharmica, LLC committed to providing a formal written response to the current observation within fifteen business days.