FDA 483 - Vegewax Candleworx Ltd. - October 19, 2023

An FDA inspection of Vegewax Candleworx Ltd. in Concord revealed significant deficiencies in their quality control unit and manufacturing processes. Observations included a lack of written quality unit responsibilities, inadequate identity testing of drug product components, and failure to verify supplier Certificates of Analysis for Active Pharmaceutical Ingredients. The firm also failed to thoroughly investigate out-of-specification results and did not properly review production and control records before product release, indicating systemic quality control issues.