USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit

Torrent Pharmaceuticals said Tuesday that the US health regulator has given them a Form 483 with five procedural comments after inspecting their oral manufacturing facility in Gujarat, India. According to the US Food and Drug Administration (USFDA), Form 483 is given to a company's management after an inspection if the investigator notices any conditions that might break the rules under the Food Drug and Cosmetic (FD&C) Act and related Acts.

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