Findings
1Quality 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: Adequate testing of your incoming components for identity, purity, strength, and other…
2Equipment and facility
Your firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-up (21 CFR 211.42(c)). Your firm manufactures over-the-counter (OTC) antibacterial hand soap, antiseptics, and hand sanitizer 1 drug products. You manufacture these drug products using the same equipment that you use to manufacture numerous non-pharmaceutical materials in your facility, including industrial detergents and disinfectants. It is unacceptable as a matter of…
3Cleaning 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)). Inadequate Cleaning Controls Your cleaning procedures are inadequate. You have not demonstrated that your cleaning procedure is sufficient to enable operators to clean each type of equipment in a reproducible and…
About this record
Extracted automatically from the document US FDA published on 2023-02-28. 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.
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