FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Unsafe Conditions at Vitalife, Website Claims Draw FDA Warning

Sept. 7, 2016
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Vitalife received an FDA warning letter after an inspection revealed violations of the agency’s cGMP rules. The agency also challenged claims made on Vitalife’s website related to three of its products.

An inspection last year by the FDA revealed violations of the FDA’s cGMP, including products and dietary supplements being prepared, packed and held under faulty and unsafe conditions, in addition to failure to establish and follow written procedures.

Inspectors also determined that Vitalife, dba Tabak’s Health Products, did not establish component specifications that are necessary to ensure the identity, purity, strength and composition of the dietary supplements it manufactured.

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