: 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.''
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.
The US drug regulator also asked the company to come out with a management strategy for the firm that includes the details of global corrective action and preventive action plan.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new application or supplement listing your firm as a drug manufacturer, it said.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at the Puducherry facility into the United States, it warned.
The company had said its Puducherry site currently produces six products which would not get impacted by the current development.
However, the 10 abbreviated new drug applications (ANDAs) pending approval from the Puducherry facility would get deferred till the site is reclassified, the company had explained.
Strides had said it is committed to the highest standards of quality and compliance, and would work collaboratively with the US FDA to resolve all issues addressed in the warning letter.
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