Dr. Reddy's sterile plant now meets at least minimal compliance, FDA says

Dr. Reddy's logo on capsules
Dr. Reddy's Laboratories' sterile formulations plant in Duvvada, an area of Visakhapatnam in India, received an eight-observation Form 483 in August, but the FDA has said it won't need to take regulatory action. (Dr. Reddy's Laboratories)

When Dr. Reddy’s reported last year that the FDA had found additional observations at an oncology drug formulation plant, it sounded like more of the same for the facility. But it has turned out not to be so bad, the Indian drugmaker reports. 

Dr. Reddy’s, which faces FDA concerns at a number of plants, reported today that issues outlined in an eight-observation Form 483 last August for the formulations facility in Duvvada, an area of Visakhapatnam in India, have been deemed voluntary action initiated (VAI) by the agency. 

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The VAI designation means the facility meets at least “minimally acceptable state of compliance,” and the FDA won’t take regulatory or enforcement action because of the “objectionable conditions.”

That is a step up for the sterile manufacturing facility, which was named in regulatory actions back in 2015 when a three-plant warning letter was issued by the FDA. 

That is not to say Dr. Reddy’s does not still have work to do on its manufacturing operations. It has had at least a dozen Form 483s issued for its facilities since 2017, including one this year.