Findings
1Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm failed to test incoming components prior to their use in the manufacture of artnaturals SCENT FREE HAND SANITIZER. You also relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at…
2Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Hand Sanitizer Drug Product You failed to adequately investigate the root cause of the benzene, acetal, and acetaldehyde impurities found in the artnaturals SCENT FREE HAND SANITIZER drug product. During the inspection, the investigators found that there…
3Quality unit oversight
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)). You use water as a component in the manufacture of your drug products. You failed to ensure the water system…
About this record
Extracted automatically from the document US FDA published on 2022-08-30. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
