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Pharmaceuticals / Inspections and Audits

Dr. Reddy’s Says It Satisfied FDA Concerns Over Duvvada Facility

Feb. 27, 2019

Dr. Reddy’s said the FDA declared problems identified during a September 2018 inspection of the company’s Duvvada, Visakhapatnam facility to be resolved.

The Duvvada facility was previously cited in a 2015 warning letter for potential contamination. The FDA inspected the facility in 2018, issuing a Form 483 that listed eight violations.

The FDA “has concluded that this inspection is ‘closed’ and has determined the inspection classification of this facility as Voluntary Action Initiated,” Dr. Reddy’s said.

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