FDA Warns Indian Drugmaker for Discarded Records, Scant Investigations
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.