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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