Findings
1Laboratory 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 products prior to release for distribution. For example, you rely on physical and organoleptic testing, such as appearance and odor. Furthermore…
2Material 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 21 CFR 211.84 (d)(2)). Your firm contract manufactures over-the-counter (OTC) (b)(4) drug products, including (b)(4) and (b)(4) . You failed to perform adequate identity testing of each component lot used in the…
3Process 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)). Your firm failed to validate your manufacturing processes for your OTC drug products. Your firm also failed to qualify equipment and validate your cleaning processes for non-dedicated equipment used to manufacture your OTC…
4Quality unit oversight
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishment of an adequate training program (21 CFR 211.25(a)) Performance of…
About this record
Extracted automatically from the document US FDA published on 2025-05-13. 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.
