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 firm manufactures over-the-counter (OTC) hand rub drug products (also referred to as a consumer hand sanitizer) including PureCareRx Liquid Hand Sanitizer (0.1% benzalkonium chloride). Your firm failed to establish a quality unit (QU) to…
2Material 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 adequately test your incoming components, including for identity, before using the components to manufacture your drug products…
3Stability and storage
Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). Your firm failed to implement an appropriate stability testing program. Your firm also lacked scientific rationale to support the associated labeled expiry or lack thereof. For example, you noted that any labeled expiry is based on the expiration date of the bulk concentrate active ingredient (i.e., benzalkonium chloride) used to…
About this record
Extracted automatically from the document US FDA published on 2023-09-19. 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.
