Findings
1Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm failed to establish adequate laboratory controls including microbiological testing and…
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 (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to perform adequate identity testing for each component lot used in the production of your hand sanitizer drug products, including ethanol, your active pharmaceutical ingredient. Additionally, your active pharmaceutical ingredient, ethanol, is not tested for methanol…
3Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm failed to adequately investigate a sample taken from your non-circulating, on-demand (b)(4) system. The sample was taken prior to manufacturing your (b)(4) drug product, lot (b)(4) . The sample yielded an elevated bioburden count of (b)(4)…
About this record
Extracted automatically from the document US FDA published on 2022-12-06. 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.
