Westar Nutrition Corp. dba: Viva Life Science, Inc. – FDA Warning Letter, Nov 18, 2014
On July 22, 2015, the FDA issued a Warning Letter to Westar Nutritional Corp. dba Viva Life Science, Inc., following an inspection from November 4-18, 2014. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products like Viva Kids Plus, Viva Ez Kids, B-Easy, LipoGuard, and SelGuard adulterated.
Additionally, the FDA determined that LipoGuard and SelGuard are unapproved new drugs and misbranded drugs under sections 505(a) and 502(f)(1) of the Act, respectively, due to disease treatment claims on the company's website (www.vivalife.com). These products are not generally recognized as safe and effective for their claimed uses and lack adequate directions for layperson use.
Key CGMP violations include: 1. Failure to provide adequate documentation for determining that finished batch testing ensures compliance with all product specifications (21 CFR 111.75(c)(3)). 2. Failure to establish identity, purity, strength, and composition specifications for components like Zinc Gluconate and Cyanocobalamin (21 CFR 111.70(b)(1), (2)). The firm's retesting procedures for expired raw materials and handling of out-of-
- Inspection date
- November 18, 2014
- Product type
- Food
ID · 7cd060af-cb94-45bd-895d-ca589b772c93
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