FDA 483 - Sharp Clinical Services, LLC - September 02, 2022

During an inspection conducted from August 29 to September 2, 2022, the FDA issued a Form 483 to Sharp Clinical Services, a repacker/relabeler and test laboratory located in Bethlehem, PA. The observations highlight several deviations from regulatory expectations, particularly concerning Good Manufacturing Practices. Key issues included a lack of adequate testing for in-process bulk materials, which were accepted for further processing based solely on visual inspection, rather than comprehensive identity, strength, quality, and purity assessments by the quality control unit. Furthermore, the quality control unit's responsibilities and procedures were not fully documented or consistently followed. This encompassed unvalidated seal integrity testing methods, absence of annual retain sample inspections, and deficiencies in electronic data review for HPLC systems—a repeat observation from a previous inspection. The FDA also noted that an insufficient number of drug product batches were tested to determine appropriate expiration dates, with some supporting data not originating from the facility's specific equipment. Additionally, written procedures for in-process controls were not adequately established, particularly for recording physical standards preparation, validating maximum filling run times, and verifying critical environmental conditions like humidity during production. Finally, cleaning and maintenance procedures lacked sufficient detail, leading to inconsistencies in application. Sharp Clinical Services is required to respond to these observations with corrective actions to ensure compliance with federal regulations.