1Deviation, CAPA, and investigation
Deviations from written production and process control procedures are not recorded and justified.
Inspection Record
JCB Labs LLC — FDA 483 Findings
Inspectors Monica M McClure · Janet B. AbtThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate 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.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
4Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
