Recalls & Warnings
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Posted September 1, 2022
Elite One Source Nutritional Services Warned for Manufacturing, Labeling Violations
On August 5, 2022, the FDA issued a warning letter to dietary supplement manufacturer Nutritional Laboratories International, Inc. (DBA Elite One Source Nutritional Services, Inc.) after an inspection of the company’s facility found products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP).
According to the FDA, these violations included failure to follow written procedures for quality control operations, failure to verify laboratory examination of product ingredients, and failure to verify that finished batches of dietary supplements meet product specifications for identity, purity, strength, composition, and contamination. The letter also states that the company’s products were misbranded because they do not comply with labeling requirements for dietary supplements. For example, Nutritional Laboratories International, Inc. had incorrect serving sizes declared on product labels, as well as other labeling violations.
Elite One contract manufactures supplements and supplement ingredients including calcium, vitamin K, biotin, niacin and other B vitamins, although specific product brands and names were not provided in the FDA’s letter.
The company must respond within 15 days outlining steps taken to address any violations.
For more information, use the link below.
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