FDA Warns Caraco Over Violations At Drug Plant

Law360, New York (November 4, 2008, 12:00 AM EST) -- Caraco Pharmaceutical Laboratories Ltd., a subsidiary of Indian drugmaker Sun Pharmaceutical Inc., has received a warning letter from the FDA regarding its manufacturing facility in Detroit.

“The observations set forth in the warning letter include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company's standard operating procedures,” Caraco announced on Monday.

Until all matters of concern to the FDA are resolved, the agency “may in the near term withhold approval of pending...
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