FDA Warns Drug Manufacturer Strides about Document Shredding
The Food and Drug Administration sent Strides Pharma Science a warning letter regarding violations found during an inspection in January and February of this year.
The agency’s letter, dated July 1, outlined problems in the Indian generic drug manufacturer’s quality unit, including "evidence of uncontrolled shredding of documents," says a news report.
"Strides is committed to the highest standards of quality and compliance and will work collaboratively with the FDA to resolve all issues addressed in the warning letter," the company said in a letter to the Indian stock exchange.
In the case of Strides, says the news report, the FDA inspection found multiple bags of drug production, quality and lab operation documents awaiting shredding. A binder with batch records found in a 55-gallon drum in the scrap yard included documents dated Jan. 21, 2019, seven days before the FDA inspection began.
The FDA "strongly" recommended that Strides retain a consultant to help fix the problems at the plant and requested a response to the warning letter within 15 working days.