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 211.84(d)(2)). Your firm manufactures an over-the-counter (OTC) topical drug product, (b)(4) . You failed to perform adequate identity testing of each component lot used in the manufacture of your drug product. You…
2Laboratory 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 failed to perform appropriate testing on your drug product prior to release for distribution. You stated to our investigator that assay testing was not performed on approximately (b)(4) batches of…
3Cleaning validation
Your firm failed to establish 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)). You failed to adequately validate your production and process controls used in the manufacture of your drug product. You have not completed process validation and cleaning validation studies for your non-dedicated equipment…
About this record
Extracted automatically from the document US FDA published on 2024-10-22. 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.
