FDA 483 - Universal Preserv-A-Chem Inc. - February 26, 2025

Universal Preserv-A-Chem Inc., a drug repacker in Mebane, NC, was cited for significant deficiencies in quality control during an FDA inspection. Observations included inadequate component testing and supplier qualification, insufficient laboratory controls and equipment qualification, and poor computer system controls with a lack of data integrity. Additionally, the firm's cleaning validation procedures were found to be deficient.