FDA WARNING_LETTER - Vitalab Co Inc - May 15, 2014

The FDA inspected Vitalab Co., Inc.'s manufacturing facility from May 8-15, 2014, identifying significant violations. Vitalab, along with its distributor companies (V.E. Irons, Inc., Springreen Products, Inc., and Sonne's Organic Foods, Inc.), operates as a single enterprise.

The "Vit-Ra-Tox #16 Detoxiticant" and "Vit-Ra-Tox #38 Calphonite" products were deemed unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to therapeutic claims on company websites and Facebook pages, violating section 301(d) of the Act.

The inspection also revealed serious Current Good Manufacturing Practice (cGMP) violations (21 CFR Part 111) for dietary supplements, rendering products adulterated under section 402(g)(1) of the Act. Deficiencies included: * Failure to prepare and follow written Master Manufacturing Records (MMRs) (21 CFR 111.205(a)). * Failure to establish specifications for components and finished products (21 CFR 111.70(a), (b)(1), (b)(2), (e)). * Failure to establish and follow written procedures for quality control operations (21 CFR 11