FDA EIR - Catalent Indiana, LLC - May 19, 2017

An FDA inspection of Cook Pharmica, LLC, a contract manufacturer of parenteral drug products and Class II In Vitro Fertilization (IVF) Reproductive Media Devices, was conducted from May 15-19, 2017, in Bloomington, IN. This joint inspection covered Current Good Manufacturing Practices (cGMP) for drug products and the Quality System Regulation for medical devices. The inspection identified six significant deficiencies, documented on an FDA Form 483. For pharmaceutical operations, issues included a failure to fully follow written quality unit responsibilities and procedures, such as insufficient evaluation of document changes impacting validation protocols and incomplete data review in deviation investigations (e.g., a HEPA filter leak). Additionally, written process control procedures were not consistently adhered to or documented during production. For medical devices, the firm failed to define, document, or implement essential manufacturing and quality testing procedures, adequately implement Media Fill procedures and Supplier Controls, and maintain an effective Corrective and Preventive Action (CAPA) process. Beyond the formal observations, management was also presented with nine discussion items concerning various operational aspects, including validation documentation errors, equipment calibration, and CAPA effectiveness. In response, Cook Pharmica committed to submitting a written reply to the Detroit District Director within fifteen business days.