STAT+: A troubled Sun Pharma plant fails yet another FDA inspection
A Sun Pharmaceutical plant in India that has been repeatedly cited by the U.S. Food and Drug Administration for serious quality control issues failed another inspection last month over concerns the company was not doing enough to prevent medicines from becoming contaminated.
The problems cited at the facility, which is located in Halol, involved a raft of practices that raised questions about the ability of the world’s largest generic drugmaker to properly ensure sterility, environmental conditions, and cleanliness, according to a 19-page report issued by the FDA on its website. The agency inspected the Sun plant for two weeks during the first half of last month.
The findings indicate ongoing difficulties at the plant, which is a key location for the company and has previously ran afoul of FDA inspectors during several inspections dating back nearly a decade. The subsequent reports filed by agency staffers included numerous concerns about the potential for contamination and failures to follow proper procedures.
Ed Silverman
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