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). You failed to conduct adequate investigations into out-of-specification (OOS) stability testing results and missing stability intervals for your multiple drug products. For example, our investigator observed failing assay results for Phenylephrine at 3…
2Computer 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 laboratory equipment used to generate analytical data for finished drug product release lacked restricted access and sufficient controls. There is no assurance that your systems have the appropriate controls to prevent data deletion and record…
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 lacked adequate laboratory controls. For example: Failure to Establish Adequate Test…
About this record
Extracted automatically from the document US FDA published on 2024-07-09. 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.
