Recent FDA inspections of two separate Dr. Reddy’s manufacturing plants in India resulted in one facility getting the all clear, with another receiving a notice of Voluntary Action Indicated (VAI).
The Indian drugmaker’s API production facility in Bollaram, Hyderabad, was inspected from June 12 to June 16 and the agency found “zero observations” there, the company said in a June 16 filing (PDF) with the National Stock Exchange of India.
In a separate inspection, Dr. Reddy’s formulations site in Srikakulam was issued a VAI notice, which means inspectors found and documented objectionable conditions but the agency was not prepared to take or recommend regulatory action. That inspection was conducted from May 8 to May 12.
“The Agency has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is 'closed' under 21 CFR 20.64(d)(3),” the company said in its letter to the stock exchange.
Dr. Reddy's didn't reveal any other details behind the inspections.
Dr. Reddy’s has a long history of running up against FDA inspectors. Last July, the company’s preapproval inspection of its formulations manufacturing facility dubbed FTO 11—also located in Srikakulam—resulted in two observations outlined in a Form 483.
In 2019, the company was hit with eight FDA observations at an oncology drug plant in India.