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2017/08/23
CCSB received the EIR with no Form 483
After the U.S. FDA inspection in March 2017 for its Ethyl Icosapentate facilities, CCSB received a clean Establishment Inspection Report (EIR), in which no major deficiencies were identified during the inspection, also no Form FDA-483 was required.
The previous inspection on CCSB general GMP was conducted in May 2014. That inspection was also classified as NAI (no action indicated), again with no Form FDA-483 required.
