Sun Says It Addressed FDA Observations at Caraco Factory
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Sun Pharmaceutical Industries Ltd. said it addressed Food and Drug Administration concerns about quality-control breaches at a U.S. subsidiary that was shut down by the regulator for three years because of manufacturing flaws.
Sun’s Detroit-based Caraco Pharmaceutical Laboratories Ltd. unit, which said in August 2012 it was allowed to resume drug manufacturing, received notifications from the FDA following inspections in January and May this year, according to filings obtained by Bloomberg via a Freedom of Information Act request. Inspectors noted temperature-control lapses, some improperly sealed containers and a deviation from quality-control procedures.