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 firm did not have appropriate controls over your analytical equipment and software to prevent deletion of data and record all modifications to data. Specifically, electronic data generated by your HPLC software recording the testing of drug products…
2Quality unit oversight
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records did not include all testing data to support the drug product analysis performed. Out-of-Specification (OOS) Results Not Reviewed Your quality unit (QU) only reviews printed analytical results. During the inspection, our investigator found unprocessed and…
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)). Your firm did not have adequate procedures governing the collection, review, and integration of…
About this record
Extracted automatically from the document US FDA published on 2024-05-14. 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.
