Findings
1Laboratory and QC controls
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 failed to test your hand sanitizer drug products for microbiological attributes. Without testing each batch prior to release, you lack scientific evidence that all your drug product batches were free of microbial contamination that is objectionable in view of their intended use. In response to this letter, provide a list of chemical and microbial test methods and specifications used to analyze each lot of your drug products before making a lot disposition decision, and the associated written procedures.
2Equipment 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 manufactures topical over the counter (OTC) hand sanitizer drug products. You also manufacture commercial industrial chemical products on the same manufacturing equipment as your OTC drug products. Labels for some of the industrial chemicals that preceded the manufacture of your hand sanitizer drug products state that they are…
3Material 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. 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 21 CFR 211.84(d)(2)). You failed to conduct an identity test on each lot of the components (i.e., benzalkonium chloride and glycerin) and failed to conduct adequate…
4Quality unit oversight
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 firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of your drug products. For example, your QU failed to ensure: • Validation of drug product manufacturing processes, as…
About this record
Extracted automatically from the document US FDA published on 2023-09-19. 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.
