Dr. Reddy’s Duvvada site issued Form 483 with 8 observations

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Derek Brumby)
(Image: Getty/Derek Brumby)

Related tags: Form 483, Dr Reddy's, Dr reddy, Fda, Manufacturing, Oncology, API

Dr. Reddy’s formulations and manufacturing facility in Duvvada, India, was issued a letter noting eight violations after an audit by the US FDA.

The Duvvada site manufactures the generic chemotherapy treatments azacitidine and decitabine. The facility also works on the formulations for oncology and injectable products.

This is not the first Form 483 the India-based multinational pharmaceutical company has been issued recently for one of its manufacturing plants in India. In March, the FDA delivered a Form 483 to the company’s Bollaram facility​, in the Indian state of Telangana.

A few weeks later, the company was given a Form 483 with four observations at its active pharmaceutical ingredient (API) plant​ in Jinneram Mandal, Telangana.

According to the FDA’s website, a Form 483​ is distributed at the conclusion of an inspection when observations have been made that conditions may constitute violations of the Food Drug and Cosmetic Act.

This past month, Dr. Reddy’s has made movements relating to its US manufacturing network. The company sold its antibiotic manufacturing site​ in Bristol, Tennessee. At the time the company said that selling the facility would help it focus on other business priorities.

Dr. Reddy’s also continued its divestiture activities by selling its API manufacturing plant in Hyderabad to the same company as its Bristol site. A spokesperson from Dr. Reddy’s told us, at that time, that these two transactions are otherwise unrelated. Further stating that it will again allow the company to focus on priorities such as generic manufacturing.

A spokesperson for Dr. Reddy’s could not provide us with comment at this time. 

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