FDA faults Strides Pharma for records in plant's scrap yard

: The US Food and Drug Administration has issued a warning to Strides Pharma Science Limited as there were discarded CGMP (current good manufacturing practice) documents andrecordsin the scrap yard of its plant in Puducherry.

Thewarning issued through a letter sent on July 1 said thequality systemin the facilitydoes not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugsitmanufactures.

''During inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents," the FDA said in its letter.

''Our investigator also found a blue binder containing CGMP records, including batch records for US drug products, discarded with other records in a 55-gallon drum in your scrap yard,'' the letter said.

CGMP documents in the binder were dated as recently as January 21, seven days before our inspection,it said.

The FDA team inspected the facilityfrom January 28 to February 5.

Strides Pharma had, on July 2, said it received a warning letter from the FDA on its Puducherry facilityand the site which currently produces six products will not get impacted by the current development.''