Thursday, July 25, 2013

Was Wockhardt Inspection the Goby for the Draft Guidance On What consistutes Interference with Inspections

FDA excoriates Wockhardt over missing records, standing urine

When the FDA recently drafted guidance on what constitutes interference with inspectors doing their jobs, they may have been looking at a Form 483 they wrote up for Wockhardt's Waluj, India, plant, because a new warning letter says Wockhardt was guilty of many of them.

UPDATED: Wockhardt FDA warning letter says QA staff tried to mislead inspectors

Bad news about Wockhardt's manufacturing quality keeps getting delivered to the Indian generic drugmaker. In a notification to stock exchanges Saturday, the drugmaker said it has now received a warning letter from the FDA, related to the agency's import alert announced two months ago.


Read more: QA/QC - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/topics/qaqc#ixzz2a1wMuDZp 
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