Caraco's contamination complication
In a case that may have exceeded the publicity garnered by Genzyme's plant-closing virus contamination, Sun Pharmaceuticals' unit Caraco received an unpleasant Halloween trick in 2008. Warning letter 2008-DT-05 followed the inspection of a Detroit facility conducted throughout May and into June of that year. The length of the FDA visit must surely have been a foretelling of the following lengthy letter.
The warning letter opens with a bang: the first CGMP deviation cited is failure of the quality control unit to review and approve all of a drug's production records for compliance with procedures before release of a batch. The second deviation is equally fundamental: failure to thoroughly investigate a batch or any of its components that are out of spec, and to then examine other batches and other drug products that may have been associated with the specific failure.
In one example, investigators found two instances of contaminated lots, which were not released. But Caraco assigned these incidents "a low-priority status," the letter says, without isolating the source of the contamination. And it continued releasing drugs from the same period in which the cross-contaminated lots were processed.
Caraco also neglected to extend its investigation to other potentially impacted drug products, according to the letter. The company responded in part that the products under investigation were either placed on QA Hold or the entire batch was rejected.
"We note significant inadequacies in your response, including inconsistencies with other explanations you provided previously during the inspection," says the letter, which then details those inconsistencies.