FDA 483 - Sharp Clinical Services, LLC - August 30, 2019

An FDA inspection of Sharp Bethlehem LLC in Bethlehem, PA, a drug repacker and control test lab, revealed significant deficiencies across multiple areas. Observations included inadequate environmental monitoring for non-sterile drug products, lack of audit trails for electronic records, and improper temperature control for drug product storage. Additionally, the firm's quality control unit procedures were found to be insufficient, particularly concerning complaint handling and manufacturing batch records.