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Strides plunges 8% as USFDA finds significant violation at facility

The US drug regulator said it also found a blue binder containing CGMP records.

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Last Updated: Jul 17, 2019, 04.02 PM IST
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“Multiple bags of uncontrolled CGMP documents with color coding indicating they were from drug production, quality, and laboratory operations were awaiting shredding,” USFDA said.
NEW DELHI: Shares of Strides Pharma Sciences took a beating in Wednesday’s trade after USFDA said it found adulteration and “significant violations” of current good manufacturing practice (CGMP) regulations at the company's plant in Puducherry.

“Multiple bags of uncontrolled CGMP documents with color coding indicating they were from drug production, quality, and laboratory operations were awaiting shredding,” USFDA said.

The US drug regulator said it 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 scrap yard.

The USFDA said that the uncontrolled destruction of CGMP records, and lack of adequate documentation practices raise questions about the effectiveness of quality unit (QU) and the integrity and accuracy of CGMP records.

The shares of the company closed 3.08 per cent lower at Rs 366.15 on BSE.

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