GMPs, DMHA Spell FDA Warning For Revital U International

Plano, TX, own-labeler's Smart Caps declared dietary ingredient "Octrodine," also known as 1,5-dimethylhexylamine, or DMHA. Revial's two responses failed to satisfy the agency's concerns about its GMP compliance.

Inspector removing a white card with Inspector sign from the inner pocket of his jacket. Conceptual of health, business or other inspection coming over unannounced.

Revital U International LLC failed to establish specifications for each dietary supplement it markets, including a product that the US Food and Drug Administration says contains the stimulant DMHA.

The Office of Human and Animal Food Operations West Division 3, in Dallas, of the FDA Office of Regulatory Affairs stated in a 16 October warning that the Plano, TX, firm marketed its Smart Caps weight loss product with a Supplement Facts declaring "Octodrine" as a dietary

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