AHPA note: This Warning Letter to Health One Pharmaceuticals details numerous serious deficiencies of the dietary supplement cGMPs. The letter provides a good matrix against which other manufacturers can test their own compliance with these requirements.
Food and Drug Administration
March 28, 2012
Warning Letter: Health One Pharmaceuticals Inc.
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Health One Pharmaceuticals, Inc., located at 9480 Telstar Ave. El Monte, California from September 14, 2011 to October 5, 2011. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional observations, which listed a number of the violations that cause the dietary supplement products you manufacture, (b)(4),(b)(4),(b)(4), and (b)(4), 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 products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We have received your written response on October 26, 2011, concerning our investigator's observations noted on the Form FDA 483, List of Observations that was issued to you on October 5, 2011. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violation, noted below.
The significant violations documented during the inspection include, but are not limited to, the following:
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm manufactures the product (b)(4)Dietary Supplement which contains dietary ingredients, (b)(4). However, our investigator found that you did not conduct at least one test or examination to verify the identity of any of these dietary ingredients for lot # (b)(4), as required by 21 CFR 111.75(a)(1)(i).
2. Instead, your firm relied on certificates of analysis (COAs) from your suppliers for individual dietary ingredients. Further, your firm also indicated that you conduct visual inspection of the dietary ingredients based on the description listed on the COAs. A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient (see 21 CFR 111.75(a)(2) for requirements for components that are not dietary ingredients).