USFDA issues EIR for Shilpa Medicare's R&D unit in Andra Pradesh

Shilpa Medicare announced that that the Pharmaceutical Research & Development Unit of the Company situated at Modavalasa, Vizianagaram (Dt), Andhra Pradesh region has received U.S FDA Establishment Inspection Report (EIR) with intimation of closure of inspection on 08 April 2019.

This R&D site has undergone an inspection by the USFDA during 11 February 2019 to 13 February 2019, wherein the company was issued a Form 483 with 1 (one) observation. Based on its responses and follow up actions, the USFDA has determined the inspection classification of this facility as Voluntary Action Initiated (VAI).

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