FDA EIR - Catalent Maryland, Inc. - November 04, 2019

A U.S. Food and Drug Administration (FDA) inspection of Catalent Maryland, a contract development manufacturer of biological drug products, was conducted from October 28 to November 4, 2019. The inspection, performed under guidance for biological drug products (CPGM 7345.848), covered quality, facilities, equipment, materials, production, and laboratory control systems. Key deficiencies, formally documented on a Form FDA 483, included inadequate procedures to prevent microbiological contamination of sterile drug products. Specifically, the company lacked dynamic smoke studies for an ISO 5 biosafety cabinet, experienced a lapse in cleanroom certification, and did not consistently use sterile wipes or sporicidal agents in ISO 5 areas. Additionally, written records for investigations into unexplained discrepancies, such as product color variations, were often incomplete, failing to include thorough root cause assessments (referencing 21 CFR 211.192). Verbal observations highlighted further concerns, including ineffective corrective actions, poor document control, lack of documentation for facility repairs, environmental cleanliness issues, and delays in closing investigations. Inadequate handwashing procedures for personnel entering GMP manufacturing areas were also noted. Catalent Maryland's management acknowledged these observations and committed to submitting a written response to the FDA within 15 business days, outlining corrective and preventive actions.