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)). You lacked process validation data to demonstrate that the manufacturing process used to manufacture your OTC topical pain relief product is reproducible and controlled to consistently yield drugs of uniform…
2Stability and storage
Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). Your firm assigned a (b)(4) expiry period to your OTC topical pain relief product without scientific rationale to support the labeled expiry. At the time of inspection, you lacked stability data to support the (b)(4) expiry period. There was no assurance that your drug product will remain acceptable throughout its labeled expiry…
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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to conduct…
4Material 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 failed to test incoming components used in manufacturing your finished OTC drug products to determine identity, purity, strength, and quality. Additionally, your firm did not establish a…
5Quality unit oversight
Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d). You lacked a quality unit (QU) with appropriate oversight for the manufacture of your drug products, and you did not have written quality procedures. Your firm has one SOP that does not adequately govern quality processes for CGMP. For example, you failed to ensure the following…
About this record
Extracted automatically from the document US FDA published on 2026-04-28. 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.
