FDA Scolds Another Brand Marketer, Not Its Contract Manufacturers, for GMP Failings

October 10, 2011

FDA cites the company for GMP violations, including failing to establish specifications for identity, purity, strength, and composition for its components.

In a warning letter sent September 22 to Herbal Nitro Inc., FDA holds the company, and not its contract manufacturers, responsible for Good Manufacturing Practices (GMP) infractions related to the company’s products.

“As an own-label dietary supplement distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of dietary supplements. As such, you have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce,” states FDA’s letter.

FDA’s letter cites the company for GMP violations, including failing to establish specifications for identity, purity, strength, and composition for its components and for failing to conduct tests to verify ingredient identity, as we as for insufficient recordkeeping of product distribution.

Nutritional Outlook thanks Harry Rice for the tip.

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