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 failed to perform adequate testing for your raw materials that were used to manufacture the following: OTC (b)(4) and (b)(4) drug products Specially (b)(4) , an in-process material used in…
2Process 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)). Lack of Process Validation Your firm failed to adequately validate your manufacturing process for each of your OTC drug products and qualify the manufacturing equipment used for their production. Process validation evaluates…
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, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)). Your firm failed to adequately test your over-the-counter…
4Equipment and facility
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm failed to adequately validate your equipment cleaning process to demonstrate its effectiveness to prevent potential cross-contamination between your OTC drug products and non-pharmaceutical products. You manufactured your OTC (b)(4) drug products on non-dedicated equipment, e.g., your (b)(4) tank. This equipment was also used to…
About this record
Extracted automatically from the document US FDA published on 2026-01-20. 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.
