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WARNING LETTER

La Milagrosa 1 LLC MARCS-CMS 696761 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Mario Aguirre
Recipient Title
Owner
La Milagrosa 1 LLC

100 8th St # 400b
Passaic, NJ 07055
United States

lamilagrosamex@hotmail.com
Issuing Office:
Human Foods Program

United States

April 7, 2025

WARNING LETTER

Re: CMS # 696761

Dear Mr. Aguirre:

The United States Food and Drug Administration (FDA) inspected your human food manufacturing facility located at 100 8th St # 400b, Passaic, NJ from September 17, 2024 through October 23, 2024. Your facility manufactures a variety of ready-to-eat (RTE) Latin style cheese products (such as queso fresco and queso Oaxaca), mole poblano, and fried snacks (such as palmex rueda). The inspection covered cheese production. During the inspection, FDA investigators found serious violations of 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). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations (FDA-483), listing the deviations found at your facility.

Based on FDA’s inspectional findings, we have determined that the RTE cheese products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].

We received your response to the FDA-483 via email on November 8, 2024, describing corrective actions taken and planned by your firm. Based on our review of the inspectional findings, and the response that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

Hazard Analysis and Risk-Based Preventive Controls Requirements (21 CFR Part 117, Subpart C)

1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:

I. The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
II. The written preventive controls, as required by 21 CFR § 117.135(b);
III. The written supply-chain program, as required by Subpart G;
IV. The written recall plan, as required by 21 CFR § 117.139(a);
V. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
VI. The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
VII. The written verification procedures, as required by 21 CFR § 117.165(b).

Specifically, you did not have a food safety plan with any of the required elements for any of the products manufactured by your facility, including RTE Latin style cheese products (such as queso fresco and queso Oaxaca). For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)(1)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

For your RTE Latin style cheese products (such as queso fresco and queso Oaxaca):

a. You did not identify and evaluate undeclared allergens as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control (see 21 CFR § 117.130(b)(1)(ii)). Your RTE Latin style cheese products contain milk. Undeclared allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)(ii)).

Your facility also manufactures and labels products (such as mole poblano) which do not contain milk, on the same production day as cheese. You do not perform a check at your packaging/labeling step to ensure that labels being applied to cheese products are actually for cheese products (declaring milk) and not for other products (which may not declare milk).

b. You did not identify and evaluate growth of bacterial pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control (see 21 CFR § 117.130(b)(1)(i)). Your RTE Latin style cheese products are soft and semi-soft. If not properly time/temperature-controlled, the cheese products stored in your facility are likely to support the growth of bacterial pathogens (such as ingredient-related pathogens either surviving pasteurization or added post-pasteurization, or environmental pathogens introduced in your facility). Your RTE soft and semi-soft cheese products are not subject to formulation control in your facility to prevent such growth. Growth of bacterial pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify growth of bacterial pathogens as a hazard requiring a preventive control (i.e., process controls). Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as refrigerated finished product storage. Where appropriate, process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly control the hazards (see 21 CFR § 117.135(c)(1)).

We note that you monitor and record the time and temperatures of milk being pasteurized in the pasteurizer using a wheel chart. However, you have not conducted accuracy checks that show that the thermometer for your time and temperature recording device on your pasteurizer was appropriately calibrated (see 21 CFR § 117.165(a)(1)).

In addition, your cheese is stored in a walk-in cooler overnight before being shipped. However, you did not establish a written procedure to record cooler temperatures for your cheese such as queso Fresco and queso Oaxaca, after the (b)(4) step, to prevent the growth of bacterial pathogens during storage (see 21 CFR § 117.145(a)).

c. You did not identify and evaluate contamination with environmental pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your RTE Latin style cheese products are exposed to the environment in the (b)(4) tank, in the cheese press, and on the prep tables. Employees also manually handle the cheese during the (b)(4) steps. The cheese is also exposed during the (b)(4) step in your walk-in cooler before the lids are secured on the clam shell containers. The packaged cheese does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)).

We note that your existing practices to control environmental pathogens such as Listeria monocytogenes are not adequate. For example, on September 17, 2024, an employee was observed mixing a sanitizing solution consisting of bleach and water to be used on food-contact surfaces. The employee added a quantity of bleach to a bucket of water without measuring it to ensure the solution met the concentration specified on the bleach bottle label for sanitizing food-contact surfaces.

Furthermore, employees making direct contact with your cheese products may lead to contamination from environmental pathogens such as Listeria monocytogenes. For example, on September 17, 2024 and September 18, 2024, employees were observed forming cheese with their bare hands, transferring the cheese on a cart to the walk-in cooler, then returning to forming the cheese without washing their hands or changing their gloves. The step of transferring the cheese on a cart to the walk-in cooler requires employees to touch other surfaces including a strip curtain dividing the processing room and walk-in cooler. After forming the cheese by hand and cooling, the cheese is considered RTE and does not undergo further processing to control pathogens.

This is a repeat deviation from the FDA inspection conducted in June 2023.

Your response does not reference the development and implementation of a written food safety plan to address the food safety hazards identified in the FDA-483. Your response indicates that you consulted with the Ecolab company to clean your facility, provide training for cleaning and sanitation practices, and provide cleaning and sanitation products to control Listeria bacteria in your facility. Your response also indicates that you have begun sending cheese samples to a third-party laboratory for testing for the presence of Listeria spp., Salmonella, and Coliform/Escherichia coli. Please note that finished product analysis is not a substitute for the requirement to conduct environmental monitoring to verify the effectiveness of cleaning and sanitization of your food processing environment (see 21 CFR § 117.165(a)(3)). Furthermore, your response does not include evidence such as procedures and records to capture these corrective actions. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during the next inspection.

Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B)

1. Your plant did not have adequate sanitary facilities and accommodations, as your plumbing was not adequately installed and maintained to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floors as required by 21 CFR § 117.37(b)(4).

Specifically, the floors in your two RTE cheese processing rooms do not allow for adequate drainage. On September 17, 2024 and September 18, 2024, pooled water was observed in the string cheese room while your firm was producing (b)(4) pound queso Oaxaca. The water was observed in a large pool mixed with apparent cheese residue in the back left corner of the room behind the hot water tank.

This is a repeat deviation from the FDA inspection conducted in June 2023.

Your response indicates that you replaced the floor drainage in the processing room where cheese is manufactured. Your response does not include evidence such as photographs to capture this corrective action. We will verify the effectiveness of your corrective actions during the next inspection.

2. You failed to provide hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature, as required by 21 CFR § 117.37(e).

Specifically, on September 17, 2024, the sink used for handwashing in the queso Oaxaca room was not adequate because it was not equipped with hand soap or a suitable drying method such as paper towels or a hand dryer device. This sink is used by employees who handle your RTE Latin style cheese products with their bare hands.

This is a repeat deviation from the FDA inspection conducted in June 2023.

3. Your plant equipment and utensils used in manufacturing and processing food are not designed and of such material and workmanship as to be adequately cleanable and adequately maintained to protect against contamination, as required by 21 CFR § 117.40(a)(1).

Specifically, on September 17, 2024, three wooden utensils had splinters, chips, and apparent cheese residue in the cracks. The wooden utensils are used by your employees to tie the cheese cloth around cheese curds. Once the cheese curd is wrapped in the cloth, the utensils are placed on the top of the cheese cloth, making direct contact with the RTE cheese, and pressed with a plate to separate the whey from the cheese curd. Your response does not indicate if you have made any changes to mitigate the risk of contamination of your cheese products from the use of these wooden utensils. These changes could consist of a change to your process to prevent the wooden utensils from contacting the cheese or replacing the wooden utensils with a different food grade utensil made of a non-porous and cleanable material.

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.

Please send your reply to the Food and Drug Administration, Attention: Daniel Johnson, 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; Daniel.Johnson@fda.hhs.gov. If you have any questions regarding any issues in this letter, please contact Daniel Johnson via email at: Daniel.Johnson@fda.hhs.gov. Please include reference CMS #696761 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Laura Akowuah, JD, MPH
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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