FDA to Continue to Refuse Entry to Drug Products from Kenebo Facility
The Food and Drug Administration will continue to refuse admission into the U.S. of drug products manufactured at Kanebo Cosmetics’ Odawara Japan facility, the agency said in a warning letter. According to FDA, an inspection found “significant violations of current…
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good manufacturing practice (CGMP) regulations for finished pharmaceuticals.” The agency recommended the company find a third-party consultant with CGMP expertise to assist in bringing the facility into compliance.