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

The FDA inspected Vegewax Candleworx Ltd. in Concord, ON, from October 16 to 19, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the firm's failure to adequately test samples of each component for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)), including the active pharmaceutical ingredient and testing for potential (b)(4) contamination, instead relying on unverified supplier Certificates of Analysis. This poses a serious risk, as (b)(4) contamination has led to lethal poisoning incidents. Additionally, the firm's quality control unit failed to properly review and approve drug product production and control records before batch release (21 CFR 211.192), evidenced by the release of an out-of-specification (OOS) potency batch after re-processing without a thorough investigation, and inadequate investigations into microbiological excursions in their (b)(4) system. The FDA deemed the firm's quality systems inadequate and recommended engaging a qualified CGMP consultant to audit operations and ensure compliance. The firm must respond within 15 working days with corrective actions and recurrence prevention plans. Failure to address these violations may result in FDA withholding approval of new applications and refusing admission of products into the U.S.