Findings
1Computer system validation
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your (b)(4) Fourier Transform Infrared (FTIR) Spectroscopy computerized system did not have appropriate controls in place to prevent deletion of raw laboratory data. Specifically, this data is used to create an internal certificate of analysis to release…
2Deviation, CAPA, and investigation
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). Inadequate investigations/Lack of process control You contract manufacture over-the-counter drug products including benzalkonium chloride-based hand sanitizer. 1 Multiple batches of hand sanitizer drug product failed microbial total plate count…
3Laboratory 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)). You released and distributed multiple reworked batches and newly reformulated batches of your hand…
About this record
Extracted automatically from the document US FDA published on 2021-12-14. 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.
