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) topical drug products such as sunscreens, pain relief, and acne treatments. Your Quality Unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, your…
2Deviation, CAPA, and investigation
Your firm failed to document at the time of performance required laboratory control mechanisms and to record and justify any deviations from required laboratory control mechanisms (21 CFR 211.160(a)). Your firm uses PW as a component to manufacture your drug products. You failed to follow your water system procedure, including performing appropriate sampling of your water system on a (b)(4) basis and routinely documenting the monitoring of pressure gauges. In addition, our…
3Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You have not demonstrated that your cleaning procedures are adequate to prevent cross-contamination between the OTC drug products and nondrug products manufactured at your facility. Your firm utilizes (b)(4) filling lines during manufacturing of your drug products, which are shared among multiple drug products and cosmetics. Our investigator…
About this record
Extracted automatically from the document US FDA published on 2022-08-16. 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.
