Strides Pharma gets USFDA warning

Hyderabad: 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 and records in the scrap yard of its plant in Puducherry.

The warning issued through a letter sent on July 1 said the quality system in the facility does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. ''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 facility from January 28 to February 5. Strides Pharma had, on July 2, said it received a warning letter from the FDA on its Puducherry facility and the site which currently produces six products will not get impacted by the current development.''

Summerising the 'significant violations' of CGMP, the FDA asked the drug-maker to provide an assessment of the extent of data integrity deficiencies at the facility and also identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies.