Findings
1Quality unit oversight
Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). Your quality unit (QU) failed to provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Appropriate laboratory determination of satisfactory conformance to final specifications for your finished drug…
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)). Your firm manufactures over-the-counter (OTC) antibacterial hand soap and hand sanitizer drug products without adequate assurance of the quality of…
3Equipment and facility
Your firm failed to establish adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm lacked adequate equipment cleaning and maintenance procedures. For example, You lacked adequate written procedures describing your cleaning process and appropriate documentation of your equipment cleaning. Your production equipment cleaning is performed by rinsing with water and using rags for an unspecified length of time. You manufactured drug…
About this record
Extracted automatically from the document US FDA published on 2024-01-09. 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.
