Captek Softgel International



FDA Warning for Private Label Distributors

On April 26, 2013 the FDA issued a warning letter that states “As a distributor that contracts with other manufacturers to manufacture, package or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to whether your dietary supplement products conform to established specification and whether to approve and release the products for distribution”.
This particular letter goes beyond the typical warning letter from the FDA, emphasizing even more the private label’s responsibility to ensure that all cGMPs are followed.
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