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 to the Goa unit of Glenmark Pharma, summarized violations of current good manufacturing practices.
CNBC-TV18 accessed details of the warning letter, which says the company has not thoroughly investigated any unexplained discrepancies.
Glenmark’s Goa Unit was investigated by the USFDA from May 12-20, 2022 and placed under Official Action Indicated (OAI) status in August. An OAI classification by the FDA indicates that objectionable manufacturing conditions have been found at the facility and regulatory action is imminent.
The warning letter further states that no adequate procedures have been established for production and process control. The company has not established or followed 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.