FDA warns Strides Pharma for uncontrolled document shredding
The FDA warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results.
In a securities disclosure issued on 2 July, Strides acknowledged receiving the warning letter but said that the letter will not impact production of six FDA approved generic drugs made at the site, but that 10 abbreviated new drug applications (ANDAs) awaiting FDA approval “will get deferred till the site is reclassified.”
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