Inspectors allegedly found discarded records in a 55-gallon drum in the company’s scrapyard and discovered records awaiting shredding at one of Strides’ manufacturing facilities.
The agency sent a warning letter to Strides CEO Arun Kumar detailing the violations. The letter, sent July 1, was made public July 16.
“The uncontrolled destruction of records, and your lack of adequate documentation practices, raise questions about the effectiveness of your [quality unit] and the integrity and accuracy of your records,” the warning letter reads.
Strides manufactures several medications, including ibuprofen and losartan, one of the drugs involved in a series of nationwide recalls over a potentially carcinogenic impurity.
The warning letter also details other violations by Strides, including failing to adequately investigate an impurity found in an active ingredient used to make a drug. The FDA redacted the name of the drug in the warning letter.
Access the full warning letter here.
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