Inspection Record

Intas Pharmaceutical Limited — FDA 483 Findings

US FDAInspected 2025-09-17Published 2026-05-26 3 findingsDocumentation and recordsQuality unit oversightDeviation, CAPA, and investigation

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

Findings

1Documentation and records

Batch production and control records do not include complete info1mation relating to the production and control of each batch.

2Quality unit oversight

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

3Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been ah eady distributed.

About this record

Extracted automatically from the document US FDA published on 2026-05-26. 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.

Intas Pharmaceutical Limited company profile — full history US FDA documents, 2026 Go to Findings search