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  5. Anatox Inc. - 508278 - 04/26/2017
  1. Warning Letters

WARNING LETTER

Anatox Inc. MARCS-CMS 508278 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Recipient:
Recipient Name
Mrs. Julia O. Irons
Recipient Title
Owner
Anatox Inc.
Anatox Inc.

22435 Adobe Rd.
Cottonwood, CA 96022
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

8050 Marshall Drive
Suite 205
Lenexa, KS 66214-1524
United States

913-495-5100

Mrs. Julia O. Irons, Owner
Anatox Inc.
22435 Adobe Rd.
Cottonwood, CA-96022

 

Dear Mrs. Irons:

The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 30650 Terry Drive, Richland, Missouri on August 31 through September 14, 2016. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplement products 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 CGMP requirements for dietary supplements.  Our investigators’ observations were noted on Form FDA 483, Inspectional Observations, issued to and discussed with you on September 14, 2016. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.

The inspection revealed the following significant violations:

  • You failed to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, as required in 21 CFR 111.70(e). Specifically, your firm has not established specifications for the identity, purity, strength, and composition for any finished batches of the dietary supplements which you manufacture, including but not limited to the following:
    • Sonnes No. 7 Detoxificant (Lot# 051018-2) (Lot# 051718-2) (Lot# 062218-5) (Lot# 062818-2)
    • VIT-RA-TOX No. 19 Intestinal Cleanser (Lot# 021218-5) (Lot# 083118)

We have reviewed your responses dated October 5 and November 17, 2016. In your response from October 5, 2016, you provided specification sheets for your Detoxificant and Intestinal Cleanser products.

These specification sheets stated that identity was established using organoleptic properties including “visual,” “touch,” “odor,” “taste,” for your Detoxificant product. While we recognize that gross organoleptic is an acceptable test or examination method for identity testing, it may not however, be an appropriate test for certain substances. Specifically, organoleptic testing is only appropriate for substances that can be distinctly identified by a qualified botanist; for example, a raw plant material. It is not appropriate for finished dietary supplement products.

For your Intestinal Cleanser product, you provided HPTLC as an identity test. However, the identity test is inadequate because you failed to identify which chemical or reference standard will be used to meet the required specifications. In addition, you have also not established specifications for the purity, strength, and composition of your finished dietary supplement products.

Once you have established finished product specifications, you must verify that the specifications are met, as required in 21 CFR 111.75(c), and you must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required in 21 CFR 111.75(h)(1). Additionally, in your response from October 5, 2016, you provided a sampling plan. This sampling plan does not specify how you will test your finished dietary supplement products to ensure that they meet product specifications.

  • You failed to establish an identity specification for each component, as required in 21 CFR 111.70(b)(1). Specifically, your firm has not established specifications for the identity of any of the components used in the manufacturing of dietary supplements, including, but not limited to the following:
    • Sonnes No. 7 Detoxificant (Lot# 051018-2) (Lot# 051718-2) (Lot# 062218-5) (Lot# 062818-2)
    • VIT-RA-TOX No. 19 Intestinal Cleanser (Lot# 021218-5) (Lot# 083118)

We have reviewed your responses dated October 5 and November 17, 2016. In your response from October 5, 2016, you stated that you will develop a suitable combination of verification tools to adequately qualify components under your SOP P-01. You also stated that your existing component identification and verification methods require QC/QA personnel to identify all components through organoleptic identification and qualifying information from the supplier’s COA. However, we are unable to evaluate the adequacy of your response because you have not provided specifications for components which you use in the manufacture of your dietary supplements.

We note that once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency for an exemption under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. Further, you must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). A Certificate of Analysis may not be used in lieu of an identity test. You must also 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), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).

Additionally, in your response from October 5, 2016, you stated that you have verified dietary ingredients “in due course of manufacturing,” including organoleptic reviews at “critical manufacturing stages,” and provided an SOP to this effect. In your response dated November 17, 2016, you provided a revised SOP regarding the testing for identity of dietary ingredients. We are unable to evaluate the adequacy of your responses because you have not provided records of the tests used to verify the identity of dietary ingredients prior to their use (e.g., HPTLC).

This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. You should take prompt action to correct these violations and prevent their reoccurrence. Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur.   Your response should include any documentation necessary to show that corrective action has been achieved.  If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.

Please send your reply to the attention of:
Miguel Hernandez
Director, Compliance Branch
U.S. Food and Drug Administration
Kansas City District, Suite 205
8050 Marshall Drive
Lenexa, Kansas 66214

If you have any questions regarding any issue in this letter, please contact Danial S. Hutchison, Compliance Officer at (913) 495-5154 or Danial.Hutchison@fda.hhs.gov.

Sincerely,
/S/
Cheryl A. Bigham
District Director
Kansas City District

cc:
Ms. Sharla L. Swope, President
Anatox Co Inc.
30650 Terry Drive
Richland, MO 65556-8104

 

 
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