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| Exchange Disseminated Time 08/07/2016 13:21:37 | | Cadila Healthcare Ltd has informed BSE that the Company's Moraiya manufacturing facility has received an Establishment Inspection Report (EIR) from the USFDA. This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014. What is "closed" is the initial review that resulted in the warning letter issuance. Though this is a positive step towards the resolution of the warning letter issued by the USFDA, it does not in itself indicate resolution of the warning letter. The company is in constant follow up with the USFDA for resolution of the warning letter. |
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