June 18, 2020
CMIC Pharma Science Co., Ltd.
CMIC Pharma Science Co., Ltd. announced that the company received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The surveillance inspection for non-clinical trial facilities was conducted by the FDA between December 10th and December 14th, 2018.
The inspection was conducted on general operation for non-clinical trial facilities and toxicity tests according to the Good Laboratory Practice (GLP) at CMIC’s Bioresearch Center (located in Kobuchizawa, Hokuto City, Yamanashi Prefecture) of CMIC Pharma Science, and we received great news that the inspection was completed without any indications or improvements as of June 3rd.
In addition, we would like to highlight that we have a positive track record of three FDA inspections including this case (the other two cases are Good Manufacturing Practice (GMP) Compliance Reviews at Sapporo Laboratory), and all have been completed without any problems. We remain committed to provide high quality data and services to our customers.