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) hand sanitizer drug products, including 75% alcohol hand sanitizer and (b)(4) . 1 You failed to adequately test your incoming components for identity…
2Documentation and records
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 batch records lacked information on the drug product release date and were not signed by your QU. Your QU could not locate…
3Documentation 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 batch records indicate that you did not perform microbial testing on your finished hand sanitizer drug products. Without testing each batch prior to release, you did not have scientific evidence that all drug product batches conformed to the appropriate microbial quality specifications. In…
4Process validation
Your firm failed to establish 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)). You failed to validate the manufacturing processes for your OTC hand sanitizer drug products. For example, you have not sufficiently identified critical manufacturing variables including, but not limited to, (b)(4) and time…
5Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You manufacture drug products using the same equipment that you use to manufacture non-drug industrial products such as (b)(4) and (b)(4) . Inadequate removal of residues from manufacturing equipment during cleaning can lead to contamination of drug products subsequently manufactured on the non-dedicated equipment. In your response, you provided…
About this record
Extracted automatically from the document US FDA published on 2022-10-18. 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.
