Findings
1Process validation
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 has not established that your processes used to manufacture hand sanitizer drug products are validated. In addition, you could not provide evidence that equipment qualification had been performed on your…
2Quality 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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Employees are trained and remain familiar with CGMPs (21 CFR 211.25(a)). Appropriate…
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 211.84(d)(2)). You failed to test your incoming components for identity before using the components to manufacture your drug products. This includes not testing…
4Cleaning validation
Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm is currently registered as a drug manufacturer and manufactures over-the-counter (OTC) hand rub 1 drug products (also referred to as a consumer hand sanitizer) including HAND KLEEN FOAMING INSTANT HAND SANITIZER, as well as non-drug products including industrial cleaners. It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture industrial cleaners or other non-pharmaceutical products due to the risk of cross-contamination. Our investigator also observed inadequate cleaning and maintenance of your drug manufacturing equipment. Inadequate removal of active ingredients and drug product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.
About this record
Extracted automatically from the document US FDA published on 2023-01-10. 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.
