FDA EIR - Catalent Pharma Solutions LLC - December 20, 2019

An FDA pre-approval inspection of Catalent Pharma Solutions LLC in Morrisville, NC, was conducted from December 16-20, 2019. The inspection, performed under the FDA's "Pre-Approval Inspections" Compliance Program Guidance Manual, 7346.832, aimed to verify New Drug Application (NDA) data for clinical products and assess the status of a Field Alert Report related to an Abbreviated New Drug Application (ANDA) for Tobramycin Inhalation Solution. The facility functions primarily as a contract testing laboratory with limited clinical manufacturing. During the inspection, no formal observations were issued. However, a verbal observation highlighted deficiencies in documentation practices for cleaning the compounding suite (Room 304 A&B). Specifically, cleaning between batches was recorded in individual batch records but not consistently in the room's central logbook. The company also identified mold in two facility areas on multiple dates, though it was within environmental monitoring limits, and external testing for identification was pending. Catalent Pharma Solutions LLC committed to improving its documentation practices and updating standard operating procedures to ensure consistent adherence by personnel, addressing the verbal observation proactively.