FDA finds Aurobindo sterile drug plant continues to have problems

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.