WARNING LETTER
Tova Industries, LLC
MARCS-CMS 693241 —
October 29, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Zack Melzer
Recipient Title
President
Tova Industries, LLC
2902 Blankenbaker Rd.
Jeffersontown
,
KY
40299-3841
United States
zmelzer@tovaindustries.com
Issuing Office:
Human Foods Program
United States
October 29, 2024
WARNING LETTER
Re: CMS # 693241
Dear Mr. Zachery Melzer:
On August 5, 2024 through August 8, 2024, the United States Food and Drug Administration (FDA) conducted an inspection of your dry goods and ready to eat (RTE) foods facility, located at 2902 Blankenbaker Rd. Jeffersontown, KY 40299-3841. During our inspection of your facility, the FDA investigators found serious violations of the from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and Acidified Foods regulation (21 CFR Part 114).
As an acidified food processor, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations related to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114. In addition, based upon certain criteria in Part 114, acidified food products may be adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)) in that it may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and the Acidified Food regulation through the links in FDA’s homepage at www.fda.gov.
Your significant violations were as follows:
1. A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and expertise in acidification and processing of acidified foods to comply with 21 CFR 114.83 for your Pancake Syrup, Pancake Syrup Lite, Pancake Syrup Ultra Lite, Pancake Syrup Super Lite, Pancake Syrup Sugar Free, Vanilla Extract Imitation, Vanilla Flavoring, Low Sodium Soy Sauce, Soy Sauce Economy Liquid, and Soy Sauce products.
2. As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled process including conditions for heat processing and control of pH, salt, sugar and preservative level, and source and date of the establishment of the process for each acidified food in each container size as required by 21 CFR 108.25(c)(2).
We acknowledge receipt of your response to the FDA-483 received by our office on August 21, 2024. Your response states
(b)(4)
. To date, your firm has not responded to the inquiry. Please note, that all filings marked as “Incomplete” renders them as “Not Filed”. Information on registration and filing can be found in the guidance document “Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods (LACF)”: Electronic Submissions available at: https://www.fda.gov/food/establishment-registration-process-filing-acidified-and-low-acid-canned-foodslacf/establishment-registration-and-process-filing-acidified-and-low-acid-canned-foods-lacf-electronic
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as product formulations related to your acidifed foods, process filing/SID information, and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Food regulation (21 CFR Part 114) and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Rosemary Sexton via email at: rosemary.sexton@fda.hhs.gov. Please include reference #693241 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, J.D.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
11/26/2024
Regulated Product(s)
Food & Beverages