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 over-the-counter (OTC) drug products, such as (b)(4) , sunscreens, skin protectants, (b)(4) , and hand sanitizer. You failed to conduct adequate identity testing on incoming…
2Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture your OTC drug products. During the inspection, you stated that cleaning validation studies have not been conducted to demonstrate that residues are reduced to an acceptable level, nor could you provide any…
3Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess (21 CFR 211.100(a)). Inadequate (b)(4) Validation You failed to adequately qualify your (b)(4) to ensure it produces (b)(4) that meets appropriate chemical and microbial attributes for use in your OTC drug product manufacturing and equipment…
About this record
Extracted automatically from the document US FDA published on 2025-06-10. 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.
