Dr Reddy's Labs Gets 3 USFDA Form 483 Observations at Visakhapatnam Facility
Hyderabad: The United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at Dr. Reddy's Laboratories Limited's FTO-9 manufacturing facility in Visakhapatnam, Andhra Pradesh, and issued a Form 483 containing three observations.
The inspection was conducted from October 8 to October 9, 2026, and the company has stated that it will address the observations within the stipulated timeline.
The inspection was carried out at the company’s FTO-9 facility in Visakhapatnam as part of the USFDA’s Pre-Approval Inspection process. Following the inspection, the regulatory authority issued Form 483 with three observations. Dr. Reddy’s Laboratories has not disclosed the specific details of the observations in its announcement.
Dr. Reddy’s Laboratories is a Hyderabad-headquartered pharmaceutical company engaged in the development, manufacture and supply of medicines across multiple markets. Its business operations cover generic medicines, active pharmaceutical ingredients (APIs) and services, innovative medicines, and consumer healthcare products. The company focuses on developing and supplying medicines across a range of therapeutic areas, with an emphasis on improving access to affordable healthcare.
The company has an international presence and operates manufacturing facilities and research and development centres across several countries. Its manufacturing and supply chain network supports the production and distribution of pharmaceutical products for markets including India, the United States and other international regions. The company also invests in research and development to develop generic formulations, complex products and differentiated therapies.
Research and development form a significant part of Dr. Reddy’s operations, with its capabilities spanning pharmaceutical formulations, APIs, biosimilars and other areas of drug development. The company’s research activities focus on developing medicines and expanding its product portfolio across therapeutic categories. Its manufacturing operations support the supply of medicines to patients and healthcare systems in different markets.
The FTO-9 facility in Visakhapatnam is one of the company’s formulations manufacturing facilities in India. The completion of the USFDA inspection and issuance of Form 483 with three observations mark the outcome of the inspection conducted during the two-day period. The company has stated that it will address the observations within the stipulated timeline.
The inspection outcome comes as part of the regulatory oversight applicable to pharmaceutical manufacturing facilities supplying products for regulated markets. Pre-Approval Inspections are conducted by the USFDA to assess manufacturing facilities associated with applications for drug approval. Form 483 observations communicate inspectional findings that, in the investigator’s judgement, may indicate conditions or practices that could violate regulatory requirements.
Dr. Reddy’s Laboratories has said it will address the three observations within the prescribed timeline. The company has not provided further information on the nature of the observations or the specific corrective measures planned
