FDAnews Drug Daily Bulletin

Supplement Maker Draws Warning Letter for GMP Violations, Misleading Promotion

Jan. 3, 2017

The FDA issued X2 Zero a warning letter, after investigators observed several GMP violations at the company’s Texas facility and unspecified active ingredients in its supplements.

FDA investigators noted seven GMP violations that related mostly to the company’s failure to implement written procedures to ensure the dietary supplements were manufacturer under the appropriate regulatory conditions.

Specifically, X2 Zero lacked written procedures that: described the responsibilities of its quality control operations; established specifications for steps in the manufacturing process; detailed the requirements for the review and investigation of product complaints; laid out requirements for returned dietary supplements; and specified holding and distribution operations.

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