Findings
1Stability 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)). You did not provide adequate stability data to demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period. Specifically, you reported that the expiry…
2Material 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 have not demonstrated that you are testing incoming raw materials, used to manufacture your drug products, to determine their identity. Specifically, when we requested whether you perform raw material identity testing, you stated that you identify the raw material by checking the certificate 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)). 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, in…
About this record
Extracted automatically from the document US FDA published on 2023-11-21. 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.
