Inspection Record

Dr. Reddy's Laboratories Limited CTO -- Unit 6 — FDA 483 Findings

US FDAInspected 2024-06-07Published 2024-06-20 4 findingsDeviation, CAPA, and investigationQuality unit oversightOther quality system

Inspectors Tamil Arasu · Joseph A. PiechockiThe inspectors who signed the published document.Inspector lookup

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any ofits components to meet any ofits specifications whether or not the batch has been already distributed.

2Quality unit oversight

There is a failure to ensure that materials are not released before the satisfactory completion ofevaluation by the quality unit.

3Other quality system

There is a failure to ensure that manufacturing processes are maintained in a validated state.

4Other quality system

Analytical methods were not validated or verified under the actual conditions of use.

About this record

Extracted automatically from the document US FDA published on 2024-06-20. 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.

Dr. Reddy's Laboratories Limited CTO -- Unit 6 company profile — full history US FDA documents, 2024 Go to Findings search