The U.S. Food and Drug Administration (FDA) has flagged violations at a large manufacturing facility in India, which distributes biologics and drugs in the United States. The FDA issued a Form 483 with seven inspection observations following a recent review of Dr. Reddy’s Laboratories, a biologics manufacturing facility in Bachupally, Hyderabad, India. The agency has not publicly disclosed the specific observations.1
The FDA conducted the inspection from June 16 to June 25, 2026. At the end of the visit, inspectors issued a Form 483, which identifies conditions that may violate FDA regulations. A Form 483 does not mean a company has broken the law but it serves as a notice that inspectors found issues requiring the company’s attention.2 Dr. Reddy’s Laboratories did not disclose the specific observations cited by FDA inspectors but said it will address all seven observations within the FDA’s required timeframe.3
Latest Inspection Builds on Earlier FDA Review
The latest inspection follows previous FDA reviews of the same facility. In September 2025, the agency conducted a pre-approval inspection, which is performed before the FDA decides whether to approve a biologic manufactured at a facility. That inspection resulted in a Form 483 containing five observations.4 According to the FDA inspection report, one observation involved problems with the facility’s environmental monitoring records. Inspectors found differences between the original testing data and the results reported by the company, as well as inaccuracies in records tracking the presence of microorganisms in the manufacturing environment.5
Dr. Reddy’s biologics division is developing DRL_RI (Ituxredi), a proposed biosimilar to Rituxan (rituximab). The Bachupally facility is part of the company’s biologics manufacturing network. Rituximab is a monoclonal antibody used to treat several diseases, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris. The FDA’s review includes an evaluation of both the biologic product and the manufacturing facility where it will be produced.On July 12, 2023, Dr. Reddy’s announced that the FDA had accepted for review its Biologics License Application (BLA) for DRL_RI; however, the application still remains under FDA review.6
According to ProPublica, Dr. Reddy’s Laboratories also manufactures several sterile injectable generic medicines distributed in the United States. These products include azacitidine, which is used to treat certain blood cancers; bortezomib, which is used to treat multiple myeloma and mantle cell lymphoma; daptomycin and doxycycline hyclate for injection, which are antibiotics used to treat bacterial infections; and enalaprilat injection, which is used to treat high blood pressure when oral therapy is not appropriate.7
Dr. Reddy’s Business Growth Continues Despite FDA Scrutiny
Despite receiving FDA inspection observations at its Hyderabad biologics facility, Dr. Reddy’s continues to introduce new generic medicines in several global markets. In June 2026, the company launched the first generic version of Pfizer’s Bosulif in the U.S. The drug is used to treat chronic myeloid leukemia (CML). Dr. Reddy’s developed and manufactures the product in partnership with MSN Laboratories. The company said the launch is intended to improve patient access to an important cancer therapy by offering a lower-cost alternative to the brand-name drug. According to Dr. Reddy’s, Bosulif generated approximately $253.8 million in U.S. sales over the past 12 months, making it a significant addition to the company’s oncology portfolio.8
Dr. Reddy’s has also expanded its diabetes portfolio. In June 2026, the company became the first manufacturer to receive Health Canada approval for a generic semaglutide injection and launched the product in Canada. It also introduced Obeda, an oral semaglutide product, in India. Both products are approved only for the treatment of Type 2 diabetes and are not approved for weight management, unlike Novo Nordisk’s Wegovy.9
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Click here to view References:1 Becker Z. FDA slaps Dr. Reddy’s Hyderabad biologics plant with seven observations in new Form 483. Fierce Pharma June 26, 2026.
2 U.S. Food and Drug Administration. FDA Form 483 Frequently Asked Questions. Jan. 9, 2020.
3 Bombay Stock Exchange. Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. June 25, 2026.
4 Becker Z. FDA slaps Dr. Reddy’s Hyderabad biologics plant with seven observations in new Form 483. Fierce Pharma June 26, 2026.
5 U.S. Food and Drug Administration. Dr. Reddy’s Laboratories, LTD, Biologics. Sept. 12, 2025.
6 Businesswire. Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA. July 12, 2023.
7 ProPublica. Dr Reddy’s Laboratories Limited. July18, 2025.
8 Becker Z. FDA slaps Dr. Reddy’s Hyderabad biologics plant with seven observations in new Form 483. Fierce Pharma June 26, 2026.
9 Ibid.
One Response
Ahhhh…. Yes. Form 483. It’s always only been a matter of time before someone whipped out good old form 483, slapped that puppy down on the bosses desk. Someone actually did something on their FDA sponsored vaca to India’s air conditioned ‘laboratories’. Nothing says astute attention to health care like outsourcing ‘biologics’ manufacturing to third world India. Brilliant! I hope he did not have to take the train. Your vaccines and other meds are certainly a side more safe and effective now. Rest easy my friend. We’ll wake you when it’s over.