US FDA issues Form 483 to Gland Pharma

Following a pre-market inspection of Gland Pharma's Pashamylaram plant in Hyderabad, the U.S. FDA issued a Form 483 to the generic injectables manufacturer with two observations.

The Office of Medical Device and Radiological Health Operations, U.S. FDA, conducted the inspection covering the quality system/current good manufacturing practice rules for medical devices (21 CFR Part 820), from August 23 to 26. Regarding the ANDA filed for the product to be produced in a PEN device at the abovementioned facility, the company has received two observations on Form 483. Gland Pharma stated in a filing on Saturday that there has been no data integrity observation.

It stated that the company is dedicated to addressing the observations and would provide the U.S. FDA with a response within the allotted period.

Source: Media Reports