FDA EIR - Catalent Pharma Solutions LLC - May 19, 2017

An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, was conducted from May 15-19, 2017. This comprehensive review, performed under drug manufacturing inspection guidelines (Compliance Program Guidance Manual 7356.002), focused on the firm's operations as a contract testing laboratory and clinical trial manufacturer. The inspection resulted in a two-item FDA Form-483, identifying significant observations. Primarily, deficiencies were noted in the responsibilities and procedures of the quality control unit, referencing 21 CFR 211.22(d). The company failed to consistently follow its own procedures for customer complaint handling, specifically regarding timely investigation completion or the formal submission of extension requests. Two customer complaints were significantly delayed without proper documentation. Additionally, one customer complaint was not initiated in the electronic system within the required five-day timeframe. Several non-conformance investigations also exceeded their 30-day completion deadline without documented extensions. Furthermore, the inspection identified inadequate control over facility areas. There was a lack of separate or clearly defined zones to prevent contamination or mix-ups, particularly concerning the storage of released drug products. Stability samples were observed in an undifferentiated "bulk storage" area, indicating insufficient operational controls. Management acknowledged the findings and committed to providing a formal response to the FDA Form-483 within 15 business days.