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

Sharp Clinical Services in Bethlehem, PA, a repacker/relabeler and test lab, was cited for five significant violations during an FDA inspection. The observations primarily concern inadequate quality control procedures, including insufficient testing of in-process materials, unvalidated seal integrity methods, lack of proper stability testing for expiration dates, and poorly defined in-process controls and cleaning procedures. These issues indicate a systemic failure to adhere to good manufacturing practices, with one observation being a repeat finding.