Findings
1Documentation and records
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)). Based on the information you provided, you did not demonstrate that your manufacturing processes are reproducible and controlled to yield a product of uniform character and quality. For example, your batch records…
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)). Your response to our request for records and other information under section 704(a)(4) indicated that you did not adequately test incoming components used in the manufacture of your drug products before release and distribution to the United States. Specifically, in response to our request to provide details about your raw material incoming and…
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 finished OTC drug products prior to release, including over 90 shipments of hand sanitizer drug products…
About this record
Extracted automatically from the document US FDA published on 2023-01-03. 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.
