virgin scent inc. – FDA Warning Letter, Mar 11, 2022

The FDA inspected Virgin Scent Inc. dba Artnaturals from February 14 to March 11, 2022, prompted by unacceptable levels of benzene, acetaldehyde, and acetal impurities in artnaturals SCENT FREE HAND SANITIZER, leading to a recall. The inspection identified significant Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated (21 U.S.C. 351(a)(2)(B)). Deficiencies included a dysfunctional quality assurance system and the Quality Control Unit's failure to ensure CGMP compliance and product specifications (21 CFR 211.22). The firm lacked written procedures for QU responsibilities, investigations, recalls, and batch release, and showed inadequate oversight of contract manufacturers. Furthermore, the firm failed to prepare complete batch production and control records (21 CFR 211.188) and did not fulfill establishment registration requirements (21 U.S.C. 360(i)(1)). Multiple drug products were not duly listed with the FDA (21 U.S.C. 360(j)), and listings failed to identify Virgin Scent as the repackager. The FDA also noted the firm's intent to distribute fire-damaged inventory, a prohibited act (21 CFR 211.208). The FDA recommends a CGMP consultant and requires a 15-working-day response detailing corrective actions, including robust procedures and QU oversight. Failure to comply may lead to further regulatory actions. The firm committed to ceasing drug production but must clarify future plans.