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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
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