Findings
1Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to investigate out-of-specification (OOS) assay results during stability checks for several batches of your antibacterial hand soap drug products. For example, assay testing for chloroxylenol in your antibacterial hand soap drug product…
2Documentation 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)). Your firm failed to adequately test your over-the-counter (OTC) drug products prior to release for distribution. For example, although your batch records for hand sanitizer 1 and antibacterial hand soap drug products include a requirement for microbial testing, you failed to test each batch for…
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 QU did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Adequate procedures describing investigation handling, quarantine products, complaint handling, change…
4Documentation and records
Your firm failed to establish adequate 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)). Your firm failed to adequately validate the manufacturing process and water system used in the manufacture of your hand sanitizer and antibacterial hand soap drug products. For example, your batch records included…
About this record
Extracted automatically from the document US FDA published on 2023-03-14. 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.
