Dr. Reddy's Laboratories Ltd announced that the United States Food & Drug Administration (USFDA) completed a GMP and a Pre-Approval Inspection (PAI) at its formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India, from July 10 to July 18, 2025. The company has been issued a Form 483 with 7 observations, which it will address within the stipulated timeline.
The inspection included both Good Manufacturing Practice (GMP) and a Pre-Approval Inspection (PAI). The company is preparing to respond to the USFDA's observations within the required timeframe.
K Randhir Singh, Company Secretary, Compliance Officer & Head-CSR of Dr. Reddy's Laboratories Limited, confirmed the issuance of the Form 483 in a filing to the stock exchanges.
The company will work to address the concerns raised by the USFDA to ensure compliance and maintain the standards of its manufacturing processes.
