Findings
1Laboratory and QC controls
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1). You lacked adequate identity testing for your incoming components, including glycerin, used to manufacture your drug products. For example, your identity test method for glycerin did not include a limit test for the presence of diethylene glycol (DEG) and ethylene glycol (EG). You did not perform adequate identity testing using the USP identification…
2Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). You failed to establish an adequate stability testing program to demonstrate that the chemical and microbiological properties of your drug products meets established specifications and remain acceptable through the 12-month expiration period for your drug products. During the inspection, you informed our…
3Complaint and recall handling
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) did not provide adequate oversight for the manufacture of your OTC drug products. For example, your firm lacked standard operating procedures (SOPs) for QU responsibilities, investigations, change controls, CAPAs, recalls…
4Laboratory 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, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to…
About this record
Extracted automatically from the document US FDA published on 2025-11-04. 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.
