Bad Drugs FDA Warning
FDA Warns about Shoddily Produced Generic DrugsJuly 6, 2017
The U.S. Food and Drug Administration (FDA) has issued a formal warning about Dr. Reddy’s Laboratories Ltd. and Lupin Ltd., two Indian manufacturers of generic drugs. For both companies, this was the fifth FDA warning issued about its products.
The agency took Dr. Reddy’s and Lupin to task for insufficiently safe manufacturing processes. The exact terms of the warning were unclear, as the report was edited. Nevertheless, the FDA stated that the companies’ quality-control measures were significantly lacking.
The FDA also cited the companies for failing to provide adequate samples, for failing to use adequate computer controls for its manufacturing processes, and for failing to explain testing discrepancies.
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