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  5. Western Innovations, Inc. - 679737 - 11/13/2024
  1. Warning Letters

WARNING LETTER

Western Innovations, Inc. MARCS-CMS 679737 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
SJ Jernigan
Recipient Title
CEO
Western Innovations, Inc.

4825 Nome St
Denver, CO 80239
United States

jerry@westerninnovationsinc.com
Issuing Office:
Human Foods Program

United States

November 13, 2024

WARNING LETTER

CMS #679737

Dear Mr. Jernigan:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 4825 Nome Street, Denver, CO, from January 29 through February 21, 2024. Based on inspectional findings, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

At the conclusion of the inspection on February 21, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated February 22 and 23, March 12, 26, and 29, and April 4 and 8, 2024, and we address your responses below.

Adulterated Dietary Supplements

The inspection of your facility on January 29 through February 21, 2024, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations (CFR), 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 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.

Your significant violations of the CGMP requirements are as follows:

1. You failed to establish component specifications for each component that you used in the manufacture of your Acetyl-glutathione dietary supplement product, as required by 21 CFR 111.70(b).

• You failed to establish an identity specification, as required by 21 CFR 111.70(b)(1). Specifically, in your February 22, 2024, response, you provided a Certificate of Analysis (CoA) for the component silica mineral hydride complex from your supplier HWH World. The methods listed on the CoA do not provide the specificity necessary for proper identification of this dietary ingredient. Furthermore, you provided CoAs from your suppliers for the silica mineral hydride complex component and the magnesium ascorbate component; however, it is unclear whether these specifications are intended to suffice as your firm’s specifications and if they have been approved by your firm’s quality control personnel.
• You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, you provided a CoA for your silica mineral hydride complex component from your supplier HWH World that is lacking strength specifications. Your finished product labeling for your Acetyl-glutathione product lists this component as being composed of enhanced silica with potassium carbonate, potassium citrate hydroxide, and magnesium sulfate.
• You failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement for your Acetyl-glutathione component, as required by 21 CFR 111.70(b)(3). Specifically, you did not provide any heavy metal or microbial test specifications for your Acetyl-glutathione component.

2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required 21 CFR 111.103. Specifically, you have not established written procedures for quality control operations. This violation was not addressed in any of your responses to Form FDA 483.

3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). The MMRs must include the required elements of 21 CFR 111.210. Specifically, the MMR you provided in your April 8, 2024, response, which you call an “(b)(4)” or “(b)(4),” is not specific to a unique formulation of a dietary supplement and is not specific to batch size.

4. Your batch production records failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your batch production records failed to include:

• A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f));
• The actual results obtained during any monitoring operation (21 CFR 111.260(g));
• The results of any testing or examination performed during the batch production, or a cross-reference to such results (21 CFR 111.260(h));
• Documentation, at the date and time of performance, of labeling operations (21 CFR 111.260(k));
• An actual or representative label, or a cross-reference to the physical location of the actual or representative label used in production (21 CFR 111.260(k)(2)).

These violations were not addressed in any of your responses to Form FDA 483.

5. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, your SOP for returned dietary supplements does not include all required information. Your response dated April 8, 2024, includes a document titled Returned Product Procedure. However, the procedure does not address the requirement for quality control to conduct a material review and make a disposition decision, as required by 21 CFR 111.510. The procedure states that the food safety officer will perform these activities. Furthermore, the procedure also does not address the requirement that if the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of the manufacturing processes and each of those other batches to determine compliance with specifications, as required by 21 CFR 111.530.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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 address 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.

In addition to the above-mentioned violations, we also have the following comment:

1. Your current finished product specification sheet for your Acetyl-glutathione product lists the test method as N/A. Please update this document to include the UPLC test method that is used to test the identity, purity, and strength of the finished product.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be addressed to Rebecca Allen, Compliance Officer, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #679737 on any submissions and within the subject line of any emails to us.

Sincerely,  
/S/ 
Maria S. Knirk, JD MBA 
Acting Director, Office of Enforcement  
Office of Compliance and Enforcement  
Human Foods Program

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