Posted March 3, 2012

FDA Warns Vitaganic of Manufacturing Violations

On February 8, 2012, the U.S. FDA sent a Warning Letter to Vitaganic, Inc. regarding violations of Current Good Manufacturing Practic (CGMP) regulations for dietary supplements found during an inspection of it manufacturing facility in Sunnyvale, California in October 2011.

Violations included failure to verify the finished batches met specifications for identity, purity, strength, composition, and for contamination limits. The FDA noted, " Your firm only weighs the finished product to ensure that all ingredients were included in the product. This is insufficient because weighing cannot detect contamination in the product and does not ensure purity, strength, or composition." In addition, Vitaganic's records "failed to include complete information relating to the production and control of each batch of your My Vitamins."

The FDA also noted that components used to manufacture Healthy Solutions Mind and Body Energy Dietary Supplement, Personal Vitamins, and Casey’s Multiples were put into those products prior to quality control operations determining whether the components met assay specifications.

The FDA required Vitaganic to notify it within 15 working days of steps taken to correct the violoations. For more details, use the link below.