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 (2)). Based on the records and information you provided, you have not demonstrated that you are testing incoming lots of the active pharmaceutical ingredient (API) used to manufacture your OTC drug products to…
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)). You did not provide adequate stability data to demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period. For example, the accelerated stability data…
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 listed OTC drug products with the FDA, including (b)(4) , such as (b)(4) , containing (b)(4) % (b)(4) . Your response to our request for records and other information under section 704(a)(4)…
About this record
Extracted automatically from the document US FDA published on 2021-08-31. 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.
