homebusiness Newscompanies NewsCNBC TV18 accesses details of USFDA warning letter on Glenmark's Goa unit: Details here
business | Dec 12, 2022 7:58 AM IST

CNBC-TV18 accesses details of USFDA warning letter on Glenmark's Goa unit: Details here

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Glenmark failed to prepare batch production and control records with complete information, according to the warning letter.

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The United States Food & Drug administration in its warning letter issued to Glenmark Pharma's Goa unit has summarised violations of current good manufacturing practices.
CNBC-TV18 has accessed details of the warning letter, which states that the company failed to thoroughly investigate any unexplained discrepancy.
Glenmark's Goa unit was investigated by the USFDA from May 12-20, 2022 and was placed under an Official Action Indicated (OAI) status in August. An OAI classification by the FDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is forthcoming.
A warning letter was issued by the regulator last month for the Goa facility, post which the company said that this will not have any impact on supplies or the existing revenue from operations of this facility.
The warning letter further states that there were no adequate procedures established for production and process control. The company failed to establish and follow the required laboratory control mechanisms, according to the warning letter.
Glenmark also failed to prepare batch production and control records with complete information, according to the warning letter.
In October, Glenmark's Baddi unit was placed under an import alert by the US drug regulator. In other words, the company cannot send any products made out of this facility to the US. The Baddi unit had been issued a warning letter by the USFDA in October 2019.
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