FDA EIR - Catalent Massachusetts, LLC - November 30, 2021

An FDA inspection of Catalent Massachusetts, LLC, located in Chelsea, MA, was conducted from November 8 to November 30, 2021. This routine inspection, part of the OPQO Division I Workplan for FY-22 under Compliance Program 7356.002 for Drug Manufacturing, focused on the company's contract manufacturing operations, specifically for Inbrija (Levodopa Inhalation Powder) Capsules, and also served as a follow-up to a previous records request. Catalent had acquired this facility and its personnel from Acorda Therapeutics, Inc. in February 2021, and its primary client remains Acorda for Inbrija production and testing. At the inspection's conclusion, a four-item FDA Form 483, detailing "Inspectional Observations," was issued to General Manager Gordon Ashton. While a comprehensive list of all four observations is not provided, one noted concern involved inconsistent procedures and inappropriate or missing contact times for cleaning agents used in manufacturing areas. Management acknowledged these concerns. In response to the observations, Catalent management committed to submitting a detailed written reply to the FDA within fifteen business days, outlining their corrective actions. No refusals or sample collections occurred during the inspection.