Aurobindo pledged to resolve issues at a sterile manufacturing plant in India last year after an FDA inspection cited it for problems that could lead to contamination. It didn’t do enough. The FDA has made another trip to the key Aurobindo facility and once again found it lacking.
The agency has posted (PDF) a Form 483 for the Unit IV facility in Pashamylaram, Hyderabad that was issued following the inspection in December. That visit came just nine months after it was written up in March of last year.
The plant is important to Aurobindo's U.S. business. It has several pending drug applications before the FDA, and the company has projected it will generate about $250 million in sales from that facility by the end of 2020.
The Form 483 contains only two observations but is 12 pages long with an extensive list of issues concerning air-flow, surface sampling and equipment cleaning that raise questions about whether the drugs coming out of the clean rooms will be free of contamination.
During the inspection in March 2018, inspectors listed nine observations that also included issues over equipment cleaning. That report also noted signs of “vermin,” including rodents and insects, in the building used for manufacturing, packaging and storage.
Aurobindo has had similar problems at another sterile manufacturing plant in nearby Bachupally. It was cited with half-a-dozen observations in 2017.
The ongoing issues in its sterile manufacturing come even as the Indian drugmaker has expanding its nonsterile drug business in the U.S. In September it agreed to pay Novartis $1 billion for a portfolio of about 300 products and several development projects in its Sandoz U.S. generic oral solids and dermatology business. The deal also includes Sandoz’ dermatology development center, as well as manufacturing facilities in Wilson, North Carolina, and Hicksville and Melville, New York, which Aurobindo said are “highly complementary” to its existing production footprint. About 750 employees from those plants and dermatology sales reps will come aboard Aurobindo.