Findings
1Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). In your 704(a)(4) records request response, you indicated that no validation activities had been performed for your drug products, including (b)(4) . Process validation evaluates the soundness of design and state of…
2Stability and storage
Your firm failed to establish 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)). Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the OTC drug products that you manufacture. For example, you assigned a (b)(4) expiry date to your drug products…
3Documentation and records
Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). The batch records you provided lacked adequate production details, including but not limited to, product formulation, identity of major equipment, duration of execution of each significant step, and identification of person(s) performing each significant step in the drug manufacturing…
About this record
Extracted automatically from the document US FDA published on 2025-06-03. 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.
