FDA 483 - Sheffield Pharmaceuticals, LLC - March 15, 2019

An FDA inspection conducted from March 11-15, 2019, identified significant quality system deficiencies at Sheffield Pharmaceuticals, LLC, a manufacturing facility in New London, CT. The company received a Form FDA 483, outlining seven observations indicating non-compliance with regulatory requirements, likely pertaining to Good Manufacturing Practices (GMP). Key observations include inadequate procedures for managing design changes, specifically concerning documentation of change rationales, impact assessments, and validation decisions. The firm's corrective and preventive action (CAPA) processes were found to be untimely, lacking completion and documented verification of effectiveness. Issues with nonconforming product disposition were also noted, with insufficient investigation and justification for product use. Equipment management presented several concerns, including failures to consistently calibrate and qualify measuring equipment according to established frequencies, and continued use of uncalibrated devices. Maintenance schedules for processing equipment lacked proper documentation for unplanned repairs, impact evaluations, and revalidation justifications. Furthermore, the firm's complaint handling system was deficient, lacking a clear definition of a complaint and failing to document rationales for decisions not to submit Medical Device Reports. Lastly, document control procedures were inadequate, leading to obsolete documents remaining in active use. Sheffield Pharmaceuticals is expected to implement prompt and thorough corrective actions to address these observations, thereby ensuring adherence to all applicable quality system regulations.