Shilpa Medicare Ltd - 530549 - Announcement Under Regulation 30
This is to inform you 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 Apr 2019. This R&D; site has undergone an inspection by the USFDA during 11 Feb 2019 to 13 Feb 2019, wherein we were issued a Form 483 with 1 (one) observation. Based on our responses and follow up actions, the USFDA has determined the inspection classification of this facility as Voluntary Action Initiated (VAI). This is for your information and doing the needful.20-04-2019