Economy
U.S. FDA issues 11 observations to Granules India facility in Hyderabad
The Hindu1h
THE BRIEF
1
Granules India's finished dosage facility in Gagillapur, Hyderabad, received 11 observations from the U.S. Food and Drug Administration following an inspection.
2
The current good manufacturing practice inspection took place from October 19 to 30 and concluded with a Form FDA 483 issuance.
3
The company stated that the observations will not impact manufacturing or distribution and that a comprehensive response will be submitted within 15 business days.