Inspection Record

Jubilant HollisterStier, LLC — FDA 483 Findings

US FDAInspected 2015-07-23Published 2024-01-17 4 findingsComplaint and recall handlingDeviation, CAPA, and investigationAseptic processing and sterility assuranceDocumentation and records

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

1Complaint and recall handling

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

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.

Jubilant HollisterStier, LLC company profile — full history US FDA documents, 2024 Go to Findings search