Inspections, Compliance, Enforcement, and Criminal Investigations

Homeodynamics, LLC 2/20/18

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Foods - West Division 1
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
(612) 334-4100 

 
 

 

February 20, 2018
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to CMS 539270
 
 
Michael J. Leger
Owner and President
Homeodynamics, LLC
7137 Lindfield Road
Madison, Wisconsin  53719-2132
 
Dear Mr. Leger:
 
On August 25, 2017, the U.S. Food and Drug Administration concluded an inspection of your facility located at 7137 Lindfield Road, Madison, Wisconsin.  During the inspection our investigators identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, and Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).  These violations cause the dietary supplements manufactured at your facility 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.  We received your firm’s FDA-483 responses dated September 20 and October 23, 2017.  We address your responses immediately following the violations identified below.
 
Additionally, we reviewed your product labels collected during the inspection and have determined that certain of your products identified below violate sections 403, 505(a), and/or 502(f)(1) of the Act, 21 U.S.C. §§ 343, 355(a), and/or 352(f)(1), and/or the regulations implementing the food labeling requirements of the Act which are found in 21 CFR Part 101.  You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drugs
 
The claims on your product labels establish that your products are drugs under section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B), because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  Examples of some of the claims that provide evidence that your products are intended for use as drugs include the following product names:  Zika Virosinum; Carcinoma Mammae; Multiple Sclerosis Nosode; Botulinum; and Dengue Fever.
 
Your products are not generally recognized as safe and effective for the above-referenced uses; therefore, the products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p).  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended, 21 CFR 201.5.  Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your Zika Virosinum, Carcinoma Mammae, Multiple Sclerosis Nosode, Botulinum, and Dengue Fever products are intended for treatment of one or more diseases that are not amendable to self-diagnosis or treatment without the supervision of a licensed practitioner.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, these products are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).  The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. § 331(a).
 
Adulterated Dietary Supplements
 
Our inspection of your facility revealed that you failed to establish and implement processes and procedures required to be in compliance with the CGMP regulations for dietary supplements found in 21 CFR Part 111. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of 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 regulations for dietary supplements.
 
1.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a).  Specifically, you do not collect reserve samples of your final products.
 
We acknowledge your response to this observation in your letters dated September 20 and October 23, 2017.  You provided a SOP entitled “SOP QC‐013 – Reserve sample collection and storage,” which indicates that you will collect reserve samples for “(b)(4).”  This corrective action is insufficient to satisfy the requirement to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute. The “(b)(4)” you describe in your response are not the same as your finished products. Reserve samples of each lot of packaged and labeled dietary supplement must be collected for use in appropriate investigations including, but not limited to, consumer complaint investigations to determine, for example, whether the dietary supplement associated with a consumer complaint failed to meet any of its specifications for identity, purity, quality, strength, and composition.
 
2.    You failed to establish and follow written procedures for your packaging and labeling operations, as required by 21 CFR 111.403.  Specifically, you have not established and followed written procedures for your packaging and labeling operations.
 
In your response dated September 20, 2017, you state that you are working on a packaging and labeling procedure; however, we have not received your written procedures for packaging and labeling operations to date.
 
3.    You failed to establish and follow written procedures for fulfilling the requirements for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; and maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(a) and (c).  Specifically, you have not established and followed written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment and utensils other than your processing area tabletop that are used to manufacture, package, label, or hold components or dietary supplements.
 
In your response dated September 20, 2017, you state that you are working on procedures for maintaining, cleaning, and sanitizing equipment and utensils; however, we have not received your written procedures to date.
 
4.    You failed to establish and follow written procedures for personnel, as required by 21 CFR 111.8.  Specifically, you have not established and followed written procedures for determining personnel qualification requirements.
 
In your response dated September 20, 2017, you state that you are working on a written procedure for fulfilling personnel qualification requirements; however, we have not received your written procedure to date.
 
Misbranded Dietary Supplements
 
Our review of the labels of your dietary supplement products revealed that your products are misbranded under section 403 of the Act, 21 U.S.C. § 343, because they do not comply with FDA’s labeling requirements under 21 CFR Part 101.
 
1.    Your Zika Virosinum, Carcinoma Mammae, Brain Whole, Ninox Sculata, Lycopodium Clavatum, Multiple Sclerosis Nosode, Aids Nosode, Botulinum, and Dengue Fever products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that the labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.4.  For example:
 
a.  Your Zika Virosinum, Lycopodium Clavatum, Brain Whole, and Dengue Fever declare the dietary ingredient sucrose but this is not the common or usual name for a dietary ingredient.
 
b.  Your Botulinum, Ninox Sculata, and Multiple Sclerosis Nosode product labels declare the dietary ingredient potassium magnesium gluconate, but this is not the common or usual name for a dietary ingredient.
 
2.    Your Zika Virosinum, Carcinoma Mammae, Brain Whole, Ninox Sculata, Lycopodium Clavatum, Multiple Sclerosis Nosode, Aids Nosodinum, Botulinum, and Dengue Fever products are misbranded within the meaning of section 403(q)(1)(A) of the Act, 21 U.S.C. § 343(q)(1)(A), because the serving size declared on the label is incorrect or incomplete.  For example:
 
a.  Your Multiple Sclerosis Nosode and Carcinoma Mammae product labels declare the serving size using the household measure “drops” and your Ninox Sculata product label states the serving size unit of measure as “sprays.”  The household measure must be followed by the equivalent metric quantity in parentheses in accordance with 21 CFR 101.9(b)(7).
 
b.  Your Zika Virosinum, Lycopodium Clavatum, Brain Whole, and Dengue Fever product labels declare the serving size using the household measure “pellets,” but the net quantity of contents is stated as a weight (ounces).  Therefore, the serving size must include the equivalent metric quantity in parentheses.  Alternatively, the net quantity of contents may state the total number of pellets.
 
c.  Your Aids Nosodinum product label fails to bear the serving size, as required by 21 CFR 101.9.
 
3.    Your Zika Virosinum, Carcinoma Mammae, Brain Whole, Ninox Sculata, Lycopodium Clavatum, Multiple Sclerosis Nosode, Botulinum, Aids Nosodinum, and Dengue Fever products are misbranded within the meaning of section 403(q)(5)(F) of the Act, 21 U.S.C. § 343 (q)(5)(F), in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36.  For example:
 
a.  Your Zika Virosinum, Carcinoma Mammae, Brain Whole, Ninox Sculata, Lycopodium Clavatum, Multiple Sclerosis Nosode, Botulinum, and Dengue Fever product labels declare a proprietary blend, but the dietary ingredients contained in the blend are not declared under the term “Proprietary Blend” in accordance with 21 CFR 101.36(c).
 
b.  Your Ninox Sculata, Multiple Sclerosis Nosode, Botulinum, and Carcinoma Mammae product labels declare potassium gluconate and magnesium gluconate as dietary ingredients contained in a proprietary blend, but fail to declare the quantitative amounts of the (b)(2)-dietary ingredients potassium and magnesium in the Supplement Facts in accordance with 21 CFR 101.36(b)(2), 101.36(c)(1), and 101.36(d).
 
4.    Your Aids Nosodinum product is misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act, 21 U.S.C. § 343(s)(2)(A)(ii)(I), in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients, as required by 21 CFR 101.36.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations 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 your firm complies with all requirements of federal law, including FDA regulations.
 
You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
We offer you the following CGMP comments:
 
We acknowledge receipt of your responses dated September 20 and October 23, 2017.  Your responses indicate that you will now be using paper funnels to assist in pouring your pellets into finished product bottles and that this addition would eliminate bare hand contact of finished products.  You also indicated that you have designated an appropriate sink as your hand wash sink and have trained all your employees in using this sink.  Your response states that you have also changed your procedures so that quality control operations are performed by individuals that have distinct and separate responsibilities, that you are no longer using an electronic records system, and that all records will be kept in paper form. In addition, your response states that you intend to complete and submit documentation regarding:  (1) establishing product specifications for the identity, purity, strength, and composition of all finished dietary supplements; (2) establishing limits for contamination that may adulterate or may lead to adulteration of all finished dietary supplements; (3) conducting at least one appropriate test or examination to verify the identity of all dietary ingredients prior to its use; (4) establishing an identity specification for each component used; (5) establishing component specifications for purity, strength, and composition; (6) ensuring that your master manufacturing records establish controls and procedures to ensure that each batch meets specifications; and (7) ensuring that batch production records include complete information relating to the production and control of each batch. The effectiveness of these corrective actions will be evaluated in a future inspection.
 
We offer you the following labeling comments:
  • The net quantity of contents declaration on your Carcinoma Mammae and Aids Nosodinum product labels must be placed within the bottom 30% of the principal display panel, 21 CFR 101.7.
  • Your Aids Nosodinum product label bears the statement “* Daily Value not established,” but the asterisk does not refer to any dietary ingredient.
  • Your Zika Virosinum, Multiple Sclerosis Nosode, Lycopodium Clavatum, Ninox Sculata, Dengue Fever, Carcinoma Mammae, Brain Whole, Botulinum, and Aids Nosodinum product labels’ information panel includes information that is considered intervening material. For example:  “Use as directed” and a product code.
  • Your Ninox Sculata, Multiple Sclerosis Nosode, Aids Nosodinum, and Botulinum product labels list terms that are not permitted within the Supplement Facts label. For example:  “organic.”
Please respond to this office in writing within 15 working days of receiving this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent their recurrence. Include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether adequate corrections have been made. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
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 reinspection-related costs.  A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
 
Your written response should be sent to Boun M. Xiong, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations

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