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.

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