Findings
1Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Based on the records and information you provided, you did not demonstrate that you are adequately testing each lot of incoming raw materials used to manufacture your drug products to determine their…
2Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Based on the records and information you provided, you did not demonstrate that you established and followed an adequate stability program to determine appropriate storage conditions and expiration dates of…
3Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm manufactured an OTC drug product, MOISTURIZING HAND SANITIZER Peppermint Scented. Your response to our request for records and other information under section 704(a)(4) indicated that you did not…
About this record
Extracted automatically from the document US FDA published on 2022-06-28. 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.
