fda_483 · inspection_citation · high

Dr. Reddy’s Laboratories, LTD, Biologics -- FDA 483: 4 observations (2025-09-12)

Event date
2025-09-12 00:00:00Z
Observed
2026-07-12 22:31:40Z
Source ID
3014250111-2025-09-12-189059
Payload hash
f4f7e47c67ba75cebe15e051

Summary

Observation 1: The Quality Unit has not established adequate procedural controls and oversight to ensure the accuracy of environmental monitoring data. Environmental monitoring data from data collecti...

Informational only. Not legal, financial, or medical advice.