Is Vita Pure Inc Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

2.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(l)(i). Specifically, you stated during the inspection that you rely on Fourier transform infrared spectroscopy (FTIR) for identity testing for dietary ingredients. While FTIR may be used to confirm that the supplier is consistent in sending the same product, FTIR does not ensure that the product received is what it is claimed to be. To verify the identity of a component that is a dietary ingredient, you must first authenticate that the ingredient is what it is stated to be, and then you may use that FTIR as a secondary authentication spectrum.

The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all of your firm's products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, such as seizure or injunction.

You should notify this office in writing within fifteen working days of receipt of this letter of the specific steps that you have taken to correct violations, including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Vita Pure Inc.

Regulatory Context

From March 2, 2017, through March 20, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 410 W. 1st Avenue, Roselle, New Jersey. Our inspection revealed significant violations of Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(l) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements found under 21 CFR Part 111. You may find the Ac

The inspection revealed the following serious violations of the CGMP requirements for dietary supplements:

1.    Your firm failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). During the inspection, you stated that the finished product specifications for dietary supplement products that you manufacture are listed on the applicable certificates of analysis (C of A) for your products. However, the C of A for your Testosterone Wellness for Men product failed to include these required product specifications.