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Posted January 17, 2015

Supplement Maker Warned for Manufacturing Violations

On August 5, 2014, the FDA issued a warning letter to Engineering Nutrition, following a facility inspection which found the company's products, which were not named, 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 establish product specifications for the identity, purity, strength, and composition of finished batches of dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of any dietary supplement, and failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement manufactured, as required by federal regulations.

See Related Warnings:

Maker of Probiotic Supplement Warned for Manufacturing Violations

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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