U.S. FDA Found Testing, Reporting Shortfalls at Sun Pharma Plant
- New issues may delay end of sanctions blocking U.S. launches
- FDA will account for Sun’s responses before final decision
This article is for subscribers only.
U.S. Food and Drug Administration inspectors in a recent visit to Sun Pharmaceutical Industries Ltd.’s plant in Halol, India, found that some testing programs weren’t adequately designed, and that failing results and potential contamination weren’t always reported in time.
Certain reports weren’t submitted to the agency within three working days on information "concerning bacteriological contamination and significant chemical, physical or other change or deterioration in a distributed drug product," FDA inspectors noted in one observation in the Halol report. The inspection concluded Dec. 1, according to the report, called a Form 483, obtained by Bloomberg News through a Freedom of Information request.