USFDA12 Dec 2025, 09:31 pm
USFDA Completes GMP, PAI Inspection at Dr Reddys Formulations Facility with 5 Observations
AI Summary
The United States Food & Drug Administration (USFDA) has completed a Good Manufacturing Practices (GMP) and Pre-Approval Inspection (PAI) at Dr Reddys Laboratories Ltd's formulations facility (FTO-SEZ PUO1) in Srikakulam, Andhra Pradesh. The inspection took place from 4th to 12th December, 2025. The company has been issued a Form 483 with 5 observations, which they have committed to address within the stipulated timeline.
Key Highlights
- USFDA completed a GMP and PAI inspection at Dr Reddys formulations facility in Srikakulam, Andhra Pradesh
- The inspection was conducted from 4th to 12th December, 2025
- Dr Reddys Laboratories Ltd received a Form 483 with 5 observations
- The company has committed to address the observations within the stipulated timeline