On March 12, 2024, the FDA issued a Warning Letter to West Coast Laboratories, Inc. following an inspection of the company’s facility which found its products including certain calcium, collagen, and chromium ingredients, to be adulterated because they were, packed, labeled or held under conditions that do not meet Current Good Manufacturing Practices (cGMP).

For more information and tests of related products, see Consumer Lab’s Reviews of Calcium and Bone Health Supplements, Collagen Supplements, and Chromium Supplements.

Violations noted by the FDA’s included failure to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, failure to establish specifications for the purity, strength, and composition of dietary supplement ingredients including at least two ingredients that are components of the company’s CalComplex formula, Naticol HPMG (a branded marine-based collagen ingredient), Aquamin F (a branded plant-based calcium ingredient), as well as other dietary supplement ingredients such as chromium picolinate, and calcium pyruvate.

The FDA also noted that the company’s Calcium Pyruvate, Chromium Picolinate, and Calcium Complex Formula #3 (CalComplex) were misbranded because the product labels fail to provide information required by federal regulations.

West Coast Laboratories, Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning: West Coast Laboratories, Inc.

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