Indoco Remedies has received regulatory status from U.S. Food and Drug Administration (USFDA), for its facilities located at Goa Plant-II & III, L-32,33,34, Verna Industrial Area, Verna, Goa, Goa 403722, India (Facility), following an inspection conducted by USFDA in July 2024.
The USFDA has determined that the inspection classification of this Facility remains as 'Official Action Indicated' (OAI).
The Facility had been inspected by the USFDA in February 2023 and had received an OAI status in May 2023.
Indoco is comprehensively working on the remedial action plan at the Facility which will be completed by Q3 2024.
Indoco had planned to inform USFDA for the inspection readiness post completion of the remedial action. However, USFDA had visited the Facility in July 2024, while the remedial action was still in progress. Hence, the compliance status of the Facility received as 'OAI' dated 10th October 2024, remains the same
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