Intas Pharmaceuticals' Indian facility hit with FDA warning letter, placed on import alert
Intas Pharmaceuticals has been issued another warning letter after FDA inspectors uncovered manipulated records and contamination issues at its facility in Gujarat, India following a 12-day inspection last May.
The warning letter sent by the FDA on Nov. 21 notes four violations including data integrity issues. This follows a Form 483, sent to Intas on May 12, detailing 15 observations. Intas responded on June 5, but the FDA deemed it “inadequate” and placed Intas on an Import Alert on Nov. 14, meaning the US can halt imports from the facility and withhold the approval of any new drugs that Intas is manufacturing until the violations have been corrected.
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