Findings
1Laboratory 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)). Based on the records and information you provided, you did not demonstrate that you adequately test your OTC finished drug products prior to release for distribution to the United States. Specifically, the…
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 for stability, you did not demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period of 24 months…
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Based on the records and information you provided, you did not demonstrate that you are testing the identity of incoming components used in the manufacture of your drug products. Additionally, you are not testing your incoming lots of (b)(4) for (b)(4) , which is used to manufacture the (b)(4) for distribution in the United States. In your response…
About this record
Extracted automatically from the document US FDA published on 2024-02-13. 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.
