The United States Food & Drug Administration (USFDA) has completed a GMP and Pre-Approval Inspection (PAI) of Dr. Reddy’s formulations facility in Srikakulam, Andhra Pradesh. The inspection, conducted from December 4th to 12th, 2025, resulted in the issuance of a Form 483 with 5 observations. Dr. Reddy’s plans to address these observations within the stipulated timeline.
USFDA Inspection Concludes
Dr. Reddy’s Laboratories announced that the USFDA concluded its inspection of the formulations facility (FTO-SEZ PU01) located in Srikakulam, Andhra Pradesh on December 12, 2025. This inspection covered both Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) standards.
Key Details of the Inspection
The USFDA’s inspection took place between December 4th and December 12th, 2025. Following the inspection, a Form 483 was issued. This form lists a total of 5 observations identified by the USFDA during their assessment of the facility’s processes and compliance.
Next Steps for Dr. Reddy’s
Dr. Reddy’s Laboratories has committed to addressing all 5 observations outlined in the Form 483. The company plans to implement corrective actions within the timeframe established by the USFDA. This will ensure continued compliance with USFDA standards and regulations.
Source: BSE