Sun Pharmaceutical Industries has received a communication from the USFDA stating that the company's Halol (Gujarat) facility has been listed under Import Alert. The Import Alert implies inter alia, that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with cGMP standards. The USFDA has excluded 14 products from this Import Alert subject to certain conditions.
The facility underwent the USFDA inspection from 26 April to 09 May 2022.
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