The US health regulator has red flagged Torrent Pharmaceuticals for significant violations of current good manufacturing practice (CGMP) regulations at its Indrad facility in Gujarat.
The United States Food and Drug Administration (USFDA) had inspected the facility from April 8 to 16, 2019.
In a warning letter issued by the regulator to Torrent Pharma's CEO Samir Mehta, the regulator said, "Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess."
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