Warning Letter: Health Breakthrough International LLC
The United States Food and Drug Administration (FDA) conducted an inspection of Health Breakthroughs International, LLC, located at 8196 SW Hall Boulevard, Suite 108, Beaverton, Oregon, on April 12, 16 and 18, 2013. During our inspection, the investigators found significant violations of the current good manufacturing practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These CGMP violations cause your dietary supplement products MPS Gold 100, MPS Gold 3X, and Amazing C to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that these dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators' observations were presented to you on Form FDA-483, Inspectional Observations, at the conclusion of our inspection on April 18, 2013.
Additionally, we reviewed the product labels for your MPS Gold 100 and MPS Gold 3X products, and have determined that those products are misbranded under section 403 of the Act [21 U.S.C. §§ 343] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA's regulations through links on the FDA's home page atwww.fda.gov.
Dietary Supplement CGMP Violations
Our inspection revealed the following violations:
1. You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i), nor has the FDA received a petition from you, and granted the petition, to exempt you from this testing requirement, pursuant to 21 CFR 111.75(a)(1)(ii). Specifically, the following products and batches lacked necessary identity testing to verify components that are dietary ingredients:
Product Dietary Ingredients Batch Numbers
MPS Gold 100 Aloe vera power, larch powder /2103204, $2103204, $2103205, 13103205, 13104205, 23104206, 23105206, 33106206
MPS Gold 3X Aloe vera power, larch powder $2103301, 13103301, 13104301, 23105301, 43106301, 43106302
Amazing C Ascorbic acid, calcium citrate, magnesium citrate, L-Glutamine $202, 1302
2. You failed to qualify a supplier of a component that is not a dietary ingredient by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, you received and relied on a COA for NAT/ART BERRY FLAVOR POWDER and INOSITOL; however you did not first qualify the supplier through confirmation of the results of their tests or examinations.
3. You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements you manufacture using those components are met, as required by 21 CFR 111.70(b)(2). For example, between the dates of December 4, 2012, and April 6, 2013, you manufactured dietary supplements approximately (b)(4) times using approximately seven ingredients. However, you have not established specifications for any of the ingredients, including larch powder and Aloe vera powder that were used in the manufacturing of your MSP Gold products; and ascorbic acid, calcium citrate, magnesium citrate, and L-Glutamine that were used in the manufacturing of your Amazing C product.
4. You failed to establish specifications for the dietary supplement labels (label specifications) and for packaging that may come in contact with the dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).
5. You failed to determine whether you met established product specifications for your finished dietary supplement products, as required by 21 CFR 111.73. Specifically, you have established finished dietary supplement product specifications for MPS Gold 100, MPS Gold 300, and Amazing C, in accordance with 21 CFR 111.70(e), but you have not tested any of your finished dietary supplement products for identity, strength, purity or composition, in accordance with 21 CFR 111.75(c).