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Posted June 13, 2012

Lack of Quality Control and Unapproved Claims by Supplement Seller

On May 14, 2012, the U.S. FDA sent a Warning Letter to Caribe Natural, LLC, distributor of GERMA brand dietary supplements, regarding violation of various FDA requirements.

Inspections of the company's Florida offices in 2011 found serious violations of the Current Good Manufacturing Practices (CGMP) regulation for deitary supplements. In addition, review of product labels on the company's website ( found that “Colostrum ‘A’ Plus” and “Urobiol” products are promoted to treat conditions that cause the products to be considered unapproved drugs. GERMA 9 Syrups, Vigaril Natural Stimulant, Germa Malt Extract with Vitamins Reinforced by B-12, and Germa Colostrum “A” Plus Dietary Supplement were were also found to be "misbranded" due to labeling violations. For details, use the link below.