Findings
1Laboratory and QC controls
Your firm failed to perform, 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)). A review of import records indicates your firm has distributed over (b)(4) lots of OTC drug products, including (b)(4) , to the United States. Your firm did not adequately test your finished OTC drug…
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)). In response to multiple requests for records pertaining to identity testing of incoming component ingredients, your firm did not demonstrate adequate testing of the identity of incoming components used in the manufacture of your drug products before release and distribution to the United States. For example, we requested details about your raw…
3Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). Your response to our records request indicates that your firm lacked an adequate stability testing program to show that the chemical properties of your drug products are acceptable throughout the claimed (labeled) expiry period of (b)(4) . For example, we requested details about your stability program, including a…
4Equipment and facility
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your response to our records requests indicates that you failed to establish that your manufacturing equipment are appropriate for their intended use and consistently operate during the manufacture of your OTC…
About this record
Extracted automatically from the document US FDA published on 2021-03-16. 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.
