Prognosis
Drugmaker Shredded Quality Documents Ahead of FDA Inspection
- Indian firm called Strides trashed data in 55-gallon drum
- Strides sells ibuprofen, pills involved in heart drug recall
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An India-based company that sells numerous drugs in the U.S., including ibuprofen, was caught attempting to dispose of quality-control records, calling into question the safety of its medicines.
U.S. Food and Drug Administration inspectors said they found what appeared to be records awaiting shredding at Strides Pharma Science Ltd.’s manufacturing facility in Puducherry, the agency said in a warning letter to Chief Executive Officer Arun Kumar made public on Tuesday. Discarded records were also found in a 55-gallon drum in the company’s scrap yard, the letter said. Ibuprofen is among the drugs the company makes at the Puducherry plant.