FDA 483_RESPONSE - Catalent Massachusetts, LLC - November 30, 2021

Catalent MA, LLC, located in Chelsea, MA, underwent an FDA inspection from November 8 to November 30, 2021. The inspection revealed several compliance issues primarily related to the requalification of equipment and adherence to Good Manufacturing Practices (GMP). Key violations included the failure to perform routine calibration of mechanical and equipment systems according to a written program, inadequate requalification of cold storage units, and incomplete assessments and requalifications due to COVID-19 staffing constraints.

Catalent's response outlined their commitment to addressing these observations through Corrective and Preventative Actions (CAPA). They acknowledged the need for a more comprehensive temperature mapping approach for environmental storage chambers to prevent undetected temperature variations. Additionally, they committed to requalifying product collection filters and membranes used in the Inbrija spray process to ensure proper sanitization and performance.

Catalent also recognized the need for a systematic review of their requalification processes and implemented a risk-based approach to categorize equipment and systems. They revised their site procedure, SOP-1068, to enhance compliance with regulatory requirements. The company emphasized its dedication to quality and compliance, supported by executive leadership, and assured the FDA of their ongoing efforts to sustain regulatory adherence.