1Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Inspection Record
Jubilant HollisterStier, LLC — FDA 483 Findings
Inspectors Investigator Rebeca Rodriguez · Investigator Debra M. Emerson · Heika R. Tait and 2 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
4Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
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.
