The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located in 69 Mall Drive, Commack, New York from May 19 through May 30, 2014. During the inspection, our investigator found a number of serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you contract manufacture, including (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 they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements in 21 CFR Part 111.
We have received your written response, dated June 18, 2014, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on May 30, 2014. 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 violations, noted below.
You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Your dietary supplement products are adulterated based on the following significant violations:
1. Your firm failed to ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, you conduct organoleptic testing to verify the identity of your powdered dietary ingredients Butcher’s Broom (used in your (b)(4), lot# (b)(4)) and Lactobacillus Acidophilus (used in your (b)(4), lot# (b)(4)). The powdered nature of these ingredients decreases the reliability of organoleptic analysis and may lead to misidentification when organoleptic analysis is the only test used. Therefore, organolepsis is not, by itself, an appropriate, scientifically valid method to verify the identity of your powdered dietary ingredients. We note that you stated that you test approximately (b)(4)% of raw materials for identity by spectroscopy through a contract testing laboratory, and your Raw Material Specification for Butcher’s Broom Powder dated April 11, 2014 indicates that you do such testing for identity on every batch; however, you did not provide any documentation demonstrating that these ingredients were actually tested in this manner. Instead, your Raw Material Release Form for Butcher’s Broom Powder (lot# (b)(4)), dated April 11, 2014, indicates that this ingredient was released for use in production based only on organoleptic, heavy metal, and microbiological testing.
Your June 18, 2014 response indicated that you have installed an FT-NIR Spectrometer that you intend to use to test all incoming raw materials for identity. We intend to verify the adequacy of your corrective action at a future inspection. Furthermore, near-IR spectroscopy is not an adequate and reliable scientific method for confirming the identity of complex proteins or bacteria, such as Lactobacillus acidophilus.
