FDA EIR - Pharmaceutics International, Inc. - November 14, 2022

This comprehensive FDA inspection of Pharmaceutics International Inc. (Pii), a contract development and manufacturing organization in Cockeysville, Maryland, was conducted from May 10 to November 14, 2022. The inspection, requested by CDER's Office of Manufacturing Quality under sterile drug process and Pre-Approval Inspection programs, aimed to assess compliance with Good Manufacturing Practices (GMP) for various drug products, focusing on sterile operations. At the inspection's conclusion, Pii received a 10-item FDA 483 "Inspectional Observations" document, highlighting significant deficiencies. Main violations included inadequate investigation of a long-term stability testing failure and persistent issues in aseptic processing areas. Specific concerns involved insufficient systems for maintaining equipment controlling aseptic conditions, and a failure to follow procedures preventing microbiological contamination during sterile manufacturing. Personnel monitoring during gowning was deemed inadequate, with operators observed improperly contacting plates. Other key issues encompassed deficient cleaning and maintenance procedures for production equipment, inadequate disinfectant efficacy studies, and failures in the Quality Control (QC) Laboratory to validate analytical methods, specifically lacking comparison data during method transfers. Furthermore, the quality unit did not fully follow its responsibilities and procedures, and both manufacturing process control and overall process control procedures were found to be inadequate. Notably, several of these observations were repeat findings from a previous 2021 inspection, indicating unaddressed systemic problems. The regulatory framework underpinning this inspection is the FDA's compliance programs for sterile drug manufacturing and pre-approval assessments. Pii is required to provide a written response to the FDA 483 outlining corrective and preventive actions for all identified deficiencies.