Findings
1Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). Your firm did not establish an adequate ongoing stability testing program to demonstrate that your hand sanitizer drug products met established specifications for identity, strength, quality, and purity for the duration of their shelf lives. Your response states that “Stability testing was ongoing during the…
2Process 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)). Process Validation Your firm failed to adequately validate the processes used to manufacture at least (b)(4) batches of your hand sanitizer drug products. In your response, you state that ethanol content in your finished…
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 adequately test your drug products for the identity and strength of the active ingredient ethanol prior to release and distribution. In your response, you state that your firm tested…
About this record
Extracted automatically from the document US FDA published on 2024-10-01. 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.
