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WARNING LETTER

Midwest Foods, LLC MARCS-CMS 677464 —


Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Jordon P. Elwell
Recipient Title
CEO/Owner
Midwest Foods, LLC

1802 N. Ankeny Blvd., Suite 113
Ankeny, IA 50023
United States

Issuing Office:
Division of Human and Animal Food Operations West II

United States


WARNING LETTER
Reference #: CMS 677464

Date: May 21, 2024

Dear Mr. Elwell:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) food manufacturing facility, located at 1802 N. Ankeny Blvd., Ste 113, Ankeny, IA 50023-1802, on December 11-13, 2023. The inspection revealed your firm manufactures salsas, sauces, dressings, and jams, with some of these products being acidified. The inspection determined there were significant violations of the Acidified Foods regulation [Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114)] and Emergency Permit Control regulation [Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)]. At the conclusion of the inspection, the FDA investigator issued you an FDA-483, Inspectional Observations, listing observations at your facility.

Based on your failure to comply with the above-mentioned requirements, we have determined that your acidified food products are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and good manufacturing practices. 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.

We acknowledge your firm's response, received on January 25, 2024, which included corrective actions your firm has taken in response to the FDA-483. However, our review determined that your firm has not addressed all the violations related to your acidified food products, as further described in this letter.

In addition, we have reviewed some of your Kramer’s Jalapeno Pepper Jam and Gino’s Italian Salad Dressing product labels that were collected during the inspection and found significant violations of the Food Labeling Regulations [Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101)]. These violations cause your product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below. You can find the Act, the Food Labeling regulation, the Emergency Permit Control regulation, and the Acidified Foods regulation through links on the FDA’s web page at www.fda.gov.

Your significant violations are as follows:

Acidified Foods Violations (21 CFR Part 108)

1. As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, 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). Your firm failed to file your scheduled processes with the FDA for each acidified food in each container size. Specifically:

•  You do not have scheduled processes on file with the FDA for 12 or 16 oz. product sizes of Kramer’s Salsa Medium, or for a 16 oz. product size of Kramer’s Salsa Inferno or Kramer’s Habanero Salsa XXXtreme. On October 3, October 17, and December 8, 2023, lots 23276, 23290, and 23342 of Kramer’s Salsa Medium were produced for packaging into 16 oz. product sizes, on September 1, 2023, lot 23244 of Kramer’s Salsa Medium was produced for packaging into a 12 oz. product size, and on April 4 and November 9, 2023, lots 23094 and 23313 of Kramer’s Salsa Inferno and Kramer’s Habanero Salsa XXXtreme were produced for packaging into 16 oz. product sizes.

We received your written response dated January 25, 2024, which states that you have “submitted a Process Authority to Cornell University” for Kramer’s Habanero Salsa XXXtreme and that you will submit the filing to FDA after review. We received your filing for this product in a 15.5 oz product size on April 26, 2024. However, to date, we have not received any new filings for each container size identified above, regarding your Kramer’s Salsa Medium, Kramer’s Salsa Inferno, or Kramer’s Habanero Salsa XXXtreme products.

2. Your firm failed to process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.25(c)(3)(i). Specifically, our investigator reviewed your scheduled processes filed with the FDA for your 15.5 oz. and 32 oz. Kramer’s Salsa Medium and Kramer’s Salsa Inferno products, and noted the following deviations from your scheduled processes filed with FDA:

•  The scheduled process for your 32 oz. Kramer’s Salsa Medium product filed with the FDA identifies a process time of (b)(4) at a processing temperature of (b)(4); however, a cook hold time was documented at (b)(4), and fill temperatures were documented as (b)(4) and (b)(4) for Kramer’s Salsa Medium lot 23269, produced on September 26, 2023.
•  The scheduled processes for your Kramer’s Salsa Medium and Kramer’s Salsa Inferno products identify an inversion time of (b)(4). During the inspection, our investigator identified that you do not keep track, nor document the number of times cases of product(s) are inverted.

Your written response states that you are working with your Process Authority to ensure that documents and processes are amended to meet the necessary requirements, and that you have implemented a deviation file. However, your response does not state that the products associated with above process deviations have undergone processes that rendered them safe. As required by 21 CFR 114.89, whenever any process operation deviates from the scheduled process for any acidified food, the commercial processor of the acidified food must either: fully reprocess that portion of the food by a process established by a competent processing authority as adequate to ensure a safe product; thermally process it as a low-acid food; or set aside that portion of the food involved for further evaluation as to any potential public health significance.

Misbranded Food

1. Your Kramer’s Jalapeno Pepper Jam is misbranded under Section 403(a)(1) [21 U.S.C § 343(a)(1)] of the Act in that the label is false or misleading because the amount of Vitamin C is less than 80% of the amount declared on the label, in violation of 21 CFR 101.9(g)(4)(ii). FDA analyzed a sample of your Kramer’s Jalapeno Pepper Jam to determine whether the nutrition information on your Nutrition Facts Label accurately reflects the nutrient content of the product. The product label at the time of collection states one serving size is 2 Tbsp (30g) and contains 10% (9 mg) of the Daily Value for Vitamin C. However, the sample analysis performed by FDA found the product to contain 1.5 mg (16.7% of the declared amount) and 0.8 mg (8.9% of the declared amount) of Vitamin C.

2. Your Kramer’s Jalapeno Pepper Jam and Gino’s Italian Salad Dressing products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the product labels fail to bear the nutrition information (e.g., Nutrition Facts Label) as required by 21 CFR 101.9. Specifically:
•  The nutrition information provided for your Kramer’s Jalapeno Pepper Jam and Gino’s Italian Salad Dressing products is not in an appropriate format and fails to declare all of the required nutrients. [21 CFR 101.9(c) and (d)].
•  Your Kramer’s Jalapeno Pepper Jam product and other jam products declare a serving size of “2 Tbsp (30 g),” which is not appropriate for a jam product. The appropriate Reference Amounts Customarily Consumed product category for your jam products is “honey, jams, jellies, fruit butter, molasses, fruit pastes, fruit chutneys” which has a reference amount of 1 tbsp. Therefore, all of the nutrition information is incorrectly declared because it is based on the wrong serving size, contrary to 21 CFR 101.9(b)(2) and 101.12(b), Table 2. We also note that the servings per container for your 8 oz. Kramer’s Jams do not comply with 21 CFR 101.9(b)(8) because of a math error. Specifically, the net weight of 226g divided by 30g serving size equals approximately 7.5 servings per container, but your Kramer’s Jams are labeled as containing 30 servings. Under 21 CFR 101.9(b)(8)(i), the number of servings must be rounded to the nearest whole number for servings above 5. Using the correct serving size of 1 tbsp (15 g), there are 15 servings per container in your 8 oz. (226 g) jam products.

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.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

In addition, we offer the following comments:

Preventive Controls

•  On December 12, 2023, during the manufacture of Gino’s Marinara Sauce, an acid food, our investigators observed that you did not document the inversion time for products. For Hot-Filled-Hold Process products, you identify a fill temperature of (b)(4) and inversion time of (b)(4) to (b)(4) as a monitoring parameter for the hazard of pathogens, at your Critical Control Point (CCP) (b)(4), Bottle Pasteurization step. Under 21 CFR 117.135(a)(2)(i), you must implement your controls at Critical Control Points.
•  As required by 21 CFR 117.145(b), you must monitor preventive controls with adequate frequency to provide assurance that they are consistently performed, and document monitoring in accordance with 21 CFR 117.145(c). Record review must be performed by (or under the oversight of) a preventive controls qualified individual, to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions, in accordance with 21 CFR 117.165(a)(4). Although your written response states that you will document product hold times moving forward and focus efforts on verifying final signatures on batch certification logs, your response does not include any documentation supporting the implementation of such monitoring and verification activities for hazards you identify as requiring a preventive control.

Labeling

•  For your Kramer’s Jalapeno Pepper Jam, we question the accuracy of the declared amount of sugars of “1g” in the Nutrition Facts Label because “sugar” is declared as the most predominant ingredient in the ingredient list.
•  Your Gino’s Italian Dressing products are missing the Net Weight in its metric equivalent. If the products are for retail sale, then the net quantity of contents should include the metric equivalent per 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA). The Gino’s Italian Dressing products may also provide the net quantity of contents in terms of the metric system as provided under 21 CFR101.7(p).
    o  Of note, “fruit preserves and jams” are a standardized food and your fruit jam products must meet the requirements under 21 CFR 150.160 if they contain an applicable fruit ingredient, such as raspberry or peach.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 response can be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Kara L. Roden, Compliance Officer or email at ORAHAFWEST2FirmResponses@fda.hhs.gov.
If you have any questions regarding this letter, please contact Kara L. Roden, Compliance Officer, at 913-495-5121 or email at Kara.Roden@fda.hhs.gov.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D.
District Director | Kansas City District Office (KS, MO, IA, NE)
Program Division Director | Office of Human and Animal Food
Operations – Division West II

 
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