Findings
1Material 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 (21 CFR 211.84(d)(1) and 211.84(d)(2)). Inadequate API Testing Your firm contract manufactures ethanol-based over-the-counter (OTC) hand rub 1 drug products (also referred to as consumer hand sanitizer). You failed to adequately test your incoming components for identity before using the components to manufacture your…
2Cleaning validation
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: Establishment of an adequate cleaning validation program for your non-dedicated equipment…
3Process 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)). Production Process Validation You failed to validate the processes used to manufacture your drug products. Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each…
About this record
Extracted automatically from the document US FDA published on 2023-04-11. 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.
