FDA 483 - Catalent Indiana, LLC - May 19, 2017

Cook Pharmica, LLC in Bloomington, IN was inspected and received a Form 483 with six observations related to significant deficiencies in their quality system, production, process controls, and CAPA procedures. The firm failed to adequately follow and document procedures for quality control, production, and process validation, particularly concerning Class II In Vitro Fertilization Reproductive Media devices. Additionally, issues were noted with vendor complaint initiation and the establishment of effective corrective and preventive actions.