Findings
1Process 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)). Your firm failed to validate the manufacturing process for NuRinse Hand Sanitizer drug product currently in distribution. Process validation evaluates the soundness of design and state of control of a process…
2Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm lacked stability data to support the expiration dates for your NuRinse Hand Sanitizer drug product currently in distribution. Without an adequate stability program, you cannot confirm that your drug…
3Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm failed to conduct adequate release testing of your NuRinse Hand Sanitizer drug product 1 . You only conducted (b)(4) , and (b)(4) testing prior to release. Full release testing, which includes…
4Material 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) and211.84(d)(2)). Your firm failed to test incoming active pharmaceutical ingredients (API) (e.g., ethanol) and other components (e.g., deionized (DI) water) used to…
About this record
Extracted automatically from the document US FDA published on 2023-03-28. 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.
