Form 483 Cites Glenmark for Controls and Storage Issues

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

The 483 cites the generic drugmaker 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. Back in July, it 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 substance of it, saying only that all the allegations had been addressed.