Earlier this month, the USFDA warned Indian generic drugmaker Strides Pharma over good manufacturing practice (GMP) violations at its Pondicherry facility. uncontrolled shredding of documents and inadequate investigations in out-of-specification (OOS) test results were some the major violations observed by the USFDA inspectors.
The warning letter states that the investigators found rampant shredding of uncontrolled documents. Some of them were already shredded and many were awaiting shredding. Documents included batch records for US drug products and the ones which were dated just one week before the inspection began.
The FDA also said that the company did not adequately investigate OOS test results for one of its APIs and closed investigation. They even manipulated the test results testing to release the API.
The FDA wants Strides to provide an assessment of the extent of data integrity deficiencies at the facility and their potential effects on the drug quality.
On 2 July, Strides acknowledged about receiving the warning letter but said that production of six FDA approved generic drugs will not be affected. Ten abbreviated new drug applications (ANDAs) awaiting the FDA approval will get deferred till the site’s reclassification.
Mr Vinod Arora, Principal Advisor, IGMPI
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