STAT Plus: An Indian drug maker sent records to its scrapyard before the FDA visited
As concerns persist over the quality of medicines made in Asia, a recent episode involving Strides Pharma, one of the largest purveyors of generic drugs, illustrates the extent of the problem.
A week before a Food and Drug Administration investigator arrived at a facility in Puducherry, India, the company had discarded documents, including batch records, in a 55-gallon drum in its scrapyard. “Multiple bags” of documents pertaining to drug productions, quality, and laboratory operations were “awaiting shredding,” according to a July 1 warning letter posted this week on the agency web site.
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