Regulations

FDA Issues Warning Letter to Maker of Carpe AP

Agency cites failure to follow CGMP.

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By: TOM BRANNA

Editor

Cosco international Inc, maker of Carpe antiperspirant, received a Warning Letter from the US Food and Drug Administration (FDA). The Agency found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Because Cosco’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, FDA deemed its drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Dru...

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