Compliance Management / Generic

India's Glenmark Pharma Slapped with Form 483

May 11, 2016

A recent Form 483 faults Indian drugmaker Glenmark Pharmaceuticals for neglecting multiple controls in its procedures at its Pithampur facility.

According to FDAnews, the 483 cites the generic manufacturer for three observations following an inspection of the facility between Feb. 22 and Feb. 26. It was the firm’s second 483 in less than a year. Last July the company was written up after an inspection revealed concerns about facility conditions, its apparent failure to follow cleaning procedures for equipment and its identification of drug samples for written specification checks.

Glenmark previously disclosed that it had received the 483, but refused to discuss the details, saying only that all the allegations had been addressed.