1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
Jubilant Generics Ltd. — FDA 483 Findings
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.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been aheady distributed.
4Documentation and records
Batch production and control records do not include complete info1mation relating to the production and control of each batch.
5Other quality system
Established laborato1y control mechanisms are not followed and documented at the time of perfonnance.
6Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies.
About this record
Extracted automatically from the document US FDA published on 2022-10-25. 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.
