Posted October 8, 2016

Seller of Cell Power and Super Silica Warned for Manufacturing Violations, Misbranding

On September 23, 2016, the FDA issued a warning letter to SSO, Inc. (dba BYS Company), following a facility inspection which found the company's products, including Cell Power and Super Silica to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement, and failure to establish and follow written procedures for the responsibilities of the quality control operations as required by federal regulations.

In addition, Cell Power and Super Silica were found to be misbranded because the labels failed to provide information required by federal regulations. For example, the labels list the ingredients as "major and trace minerals," "amino acids," "enzymes," but do not list the individual major and trace minerals, amino acids, and enzymes within the "Supplement Facts" panels.

See Related Warnings:

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below