Inspection Record

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

US FDAInspected 2020-01-28Published 2020-02-05 3 findingsOther quality systemProcess validationDeviation, CAPA, and investigation

Inspectors Aditi ThakurThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

Trend Analysis of manufactured AP l's are not conducted.

2Process validation

Process Validation is not performed adequately for manufactured products at the facility.

3Deviation, CAPA, and investigation

Investigations are inadequate in that they do not evaluate all potential root causes.

About this record

Extracted automatically from the document US FDA published on 2020-02-05. 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.

Dr. Reddy's Laboratories Limited CTO Unit VI company profile — full history US FDA documents, 2020 Go to Findings search