Bloomberg Law
Free Newsletter Sign Up
Login
BROWSE
Bloomberg Law
Welcome
Login
Advanced Search Go
Free Newsletter Sign Up

Drugmaker Shredded Quality Documents Ahead of FDA Inspection

July 16, 2019, 5:14 PM

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 July 16. 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. ...