FDA Warns Indian Drugmaker for Discarded Records, Scant Investigations

July 26, 2019

The FDA hit Strides Pharma Science with a warning letter for discarding records and other serious violations at the generic drugmaker’s facility in Puducherry, India.

FDA investigators found a binder of GMP records — including U.S. drug product batch records — along with other records in a 55-gallon drum in the facility’s scrap yard. The GMP documents were dated as recently as a week prior to the Jan. 28-Feb. 5 inspection.

The FDA officials also noted multiple bags of records of uncontrolled drug production, quality and laboratory operations awaiting shredding.

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