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Repeat violations stack up at Dr. Reddy's cancer drug plant

Management at Dr. Reddy’s oncology drug plant in India just isn’t getting the message from the FDA. In the recent inspection of the facility, more than half of the issues observed by inspectors were repeats of earlier citations.

Dr. Reddy’s acknowledged two weeks ago that the plant in Visakhapatnam had received eight observations during an October inspection but gave no specifics. The FDA today posted (PDF) the Form 483, which showed that five of the eight observations were the same kinds of problems pointed out in a visit last year. In addition, some of the observations in the March 2017 inspection were repeats from an inspection before that.

According to the highly redacted Form 483, inspectors found issues with a filling line that resulted in customers getting, and complaining about, vials of the injected cancer drug docetaxel with loose or missing seals, leaving vials exposed to potential contamination. The drugmaker recalled the batch after receiving a second complaint, but the FDA was not satisfied with how it handled the follow-up.

Additionally, the FDA said that when Dr. Reddy’s found an out-of-spec result on a batch, it didn’t investigate to see if other batches might also be affected. It was not following all procedures to prevent microbiological contamination of its sterile drugs. In addition, record keeping was not always up to standards, and field reports were not always filed on time.

The oncology formulation facility in Duvvada, India, was one of three facilities cited in a scathing warning letter in 2015 that raised a number of issues about the potential for contamination at the facility in the way that employees handled vials. The follow-up inspection in 2017 found more than a dozen issues, some of them repeats.

Dr. Reddy’s has pending ANDAs for generic cancer drugs to be produced at the plant but has been prevented by the FDA citation from launching any of them. The stranglehold by the regulator has taken a toll on Dr. Reddy’s finances, and the Indian drugmaker has responded by selling off some assets and cutting costs.

In October, the drugmaker sold its API manufacturing plant in Jeedimetla, Hyderabad, to Therapiva, a joint venture of Abu Dhabi-based Neopharma and India’s Laxai Life Sciences, an emerging generics company. No terms were disclosed. In September, Neopharma bought a 390,000-square-foot antibiotic manufacturing plant in Bristol, Tennessee.Repeat violations stack up at Dr. Reddy's cancer drug plant.

Nov 15, 2018


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