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.
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