1Other quality system
The firm failed to establish adequate document control procedures and oversight mechanisms to ensure appropriate management of written documents.
Inspection Record
Dr. Reddy’s Laboratories, LTD, Biologics — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
The Quality Unit has not established adequate procedural controls and oversight to ensure the accuracy of environmental monitoring data.
3Other quality system
Written documents are inadequate to ensure proper documentation and analysis of critical manufacturing operations.
4Contamination control
The risk assessment (QUA-BTO-2275 - Risk assessment for viral cross-contamination control in drug product manufacttiring ;it th (b)l4l nr:ility, vPrc;inn 7, npprnvPri nn August~.
About this record
Extracted automatically from the document US FDA published on 2025-10-01. 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.
