Posted September 10, 2013

CoQ10 and Carnitine Supplement Company Warned For Manufacturing Violations

On April 15, 2013, the FDA issued a warning letter to Irenda Corporation, following a facility inspection which found the company's products, including L-Carnitine, Acetyl L-Carnitine, and Co-Q 10 with L-Carnitine, to be adulterated because they were packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, failure to hold dietary supplements under conditions that do not lead to the mix-up or contamination of the supplements, and failure to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the company's facility so that it does not attract and harbor pests.

The FDA also noted that Irenda product labels include a "Best if used by" date but does not have any studies or scientific data to support these dates.

See's Reviews of Acetyl-L Carnitine Supplements and CoQ10 Supplements for tests of related products.

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