Inspection Record

Jubilant Generics Limited — FDA 483 Findings

US FDAInspected 2024-02-02Published 2024-04-05 4 findingsProcess validationDeviation, CAPA, and investigationQuality unit oversight

View the regulator's official source The source document is always the basis for judgement.

Findings

1Process validation

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

2Process validation

Time limits are not established when appropriate for the completion of each production phase to assure the quality ofthe drug product.

3Deviation, CAPA, and investigation

Written records are not always made of investigations into unexplained discrepancies.

4Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

About this record

Extracted automatically from the document US FDA published on 2024-04-05. 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.

Other records for this company

2022-08-01 · US FDA · 6 findings2022-06-06 · Health Canada · 7 findings2021-03-12 · US FDA · 7 findings
Jubilant Generics Limited company profile — full history US FDA documents, 2024 Go to Findings search