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Agency outlines issues with drug claims and more.
February 6, 2019
By: Christine Esposito
Editor-in-Chief
The US Food and Drug Administration (FDA) has sent a warning letter to Ji Hyun Min, CEO of Soleo of Korea. FDA conducted an inspection of the company’s drug manufacturing facility from August 6 to 9, 2018. The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CG...
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