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Dr Reddy’s Duvvada facility receives two observations from USFDA

Updated : June 28, 2019 09:03 AM IST

Pharma company Dr Reddy's Laboratories' Duvvada facility has received two observations from the USFDA for the inspection held between June 13 and June 21.

The observations look more procedural and benign in nature. The first observation is that the acceptance criteria were not established prior to the validation while the second is that the device designs were not correctly translated into product specifications.

The Duvvada facility is an important unit of the company. Any inspection for the facility is keenly scrutinised as the unit had once received a warning letter on the same. However, it had later got clearance from the USFDA.
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