Findings
1Documentation and records
Your firm 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(b)). You manufacture over-the-counter (OTC) drug products, such as antibacterial soaps. You failed to perform microbiological testing for your AllShield E2 Sanitizing Hand Soap. Batch records for lot 25009 indicated you did not take the required sample for microbiological testing, and quality assurance…
2Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to perform adequate identity testing on your incoming components, including active ingredients, before using them in manufacturing your AllShield E2 Sanitizing Hand Soap. Additionally, you failed to ensure that microbiological testing was performed on your benzalkonium…
3Stability and storage
Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). You informed investigators during the inspection, that you lacked a stability testing program for your AllShield E2 Sanitizing Hand Soap. Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes…
About this record
Extracted automatically from the document US FDA published on 2025-06-17. 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.
