Wednesday 24 January 2018

FDA Takes Action Against New York Cheese Manufacturer

The FDA announced today that it was seeking an injunction in Federal Court against a NY cheese manufacturer. The Agency is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.

According to a complaint for permanent injunction filed by the U.S. Department of Justice, Mexicali Cheese of Woodhaven, N.Y., and two of its officers, Edinson Vergara and Claudia Marin, produced cheese under persistent unsanitary conditions that contributed to widespread Listeria monocytogenes contamination in Mexicali Cheese’s facility.

In addition, the complaint, filed January 30 in the U.S. District Court for the Eastern District of New York, says that the New York State Department of Agriculture & Markets, Division of Milk Control and Dairy Services found similar unsanitary conditions in addition to product contamination.

Mexicali Cheese makes and distributes a variety of soft Mexican cheeses to grocery stores and supermarkets in New York, New Jersey and Connecticut. Mexicali Cheese’s products include queso fresco [fresh cheese], queso oaxaca [Oaxacan cheese] and queso para freir [cheese for frying]. If entered by the court, the injunction would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with the Federal Food, Drug, and Cosmetic Act and FDA food safety regulations.

Injunctions are reserved for the worse offenders. It often takes a series of violations before the FDA will seek an injunction. The list for Mexicali Cheese demonstrates just what it takes to qualify for a FDA injunction. Here is the full list of findings from its October Warning Letter:


The following violations were noted during the inspection of your facility:

1. Failure to conduct cleaning and sanitizing of utensils and equipment in a manner that protects food and food-contact surfaces from contamination, as required by 21 CFR 110.35(a). Specifically:

a. An employee stood in the basin of the batch pasteurizer, while wearing his soiled outer garments and soiled rubber boots, as he was cleaning the pasteurizer.

b. An employee used a hose to spray down equipment, the floor, and plastic crates during the production of ready-to-eat Queso Fresco. Water splashed up from the floor and onto food contact surfaces throughout the small production room. An uncovered bin of ready-to-eat Queso Fresco was stored on a milk crate next to where the hose was being used.

c. Blue plastic crates used to store uncovered finished product (ready-to-eat Queso Fresco) were not adequately cleaned and sanitized before use. An employee picked up the blue crates from the floor and sprayed them with water from a hose, and then used the blue crates to hold uncovered and ready-to-eat Queso Fresco.

2. Failure to properly maintain plant equipment and utensils, to preclude the adulteration of food with metal fragments or other contaminants, as required by 21 CFR 110.40(a). On August 11, 2010, investigators observed an employee using a rusted wire rack to grate mozzarella curds. The rack was coated with white enamel that was missing pieces, exposing rusted sections of the wire rack that directly contacted the mozzarella. These mozzarella curds are used to make ready-to-eat Oxaca cheese by your firm.

3. Failure to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Investigators observed the following improper employee practices and insanitary conditions on August 10, 2010:

a. An employee kneaded and mixed ready-to-eat Queso Fresco in a plastic bin and pushed ready-to-eat cheese up and over the lip of the bin where it came in direct contact with the unsanitized wall located behind the food preparation tables in the production room.

b. As an employee pressed excess liquid from chunks of ready-to-eat Queso Fresco in one compartment of the 2-compartment sink, the ready-to-eat cheese came into direct contact with the unsanitized basin and upper surfaces of the 2-compartment sink.

c. Droplets of liquid from recently rinsed blue crates used to hold finished product dripped onto uncovered rounds of ready-to-eat  Queso Fresco that were stored in crates. Employees stacked the wet blue crates on top of one another with uncovered cheese stored in the bins. The blue crates containing uncovered ready-to-eat Queso Fresco were placed on a wood dolly and wheeled through pooled water on the floor in the production area and then into the firm’s walk in cooler.

d. Uncovered ready-to-eat rounds of Queso Fresco came in direct contact with plastic strip curtains installed in the doorway between the production room and the storage room leading to the walk in cooler as they were wheeled into the cooler. Dried white debris and grime had accumulated on the plastic curtains.

4. Failure to take all necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, as required by 21 CFR 110.10(b)(9). On August 10, 2010, investigators observed food handlers wiping perspiration from their faces with their forearms and then mixing ready-to-eat Queso Fresco with their bare forearms in direct contact with the ready-to-eat cheese.

5. Failure to ensure that cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures are safe and adequate under the conditions of use, as required by 21 CFR 110.35(b). On August 10, 20I0, an investigator tested the concentration of the (b)(4) based sanitizing solution being used to clean the direct food-contact surfaces of the stainless steel food preparation tables and noted the concentration to be in excess of (b)(4) ppm. Investigators observed ready-to-eat Queso Fresco coming in direct contact with droplets of this solution that remained on the stainless steel tabletop after cleaning. Sanitizers consisting of an aqueous solution containing (b)(4) cannot exceed a concentration of (b)(4)ppm. Your firm does not have a suitable sanitizer concentration test kit available on-site to measure the concentration of sanitizer, and the spray bottle containing the sanitizing solution was not labeled as to its contents. Further, 21 CFR 178.1010 provides that sanitizing solutions may be safely used on food-processing utensils, and on other food-contact articles, only under specific prescribed conditions, which include adequate draining of the food-contact surfaces before contact with food.

6. Failure to equip your plant with adequate sanitary facilities and accommodations including, but not limited to, plumbing of adequate size and design, and that is adequately installed and maintained, to avoid constituting a source of contamination to food, water supplies, equipment, or utensils, or creating an unsanitary condition, as required by 21 CFR 110.37(b)(3), and to provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food, as required by 21 CFR 110.37(b)(5). On August 10 and 11, 2010, investigators observed a rubber hose installed in the cheese production room to be directly connected to the potable water supply without a backflow prevention device or adequate air gap installed. On August 10, 2010, investigators observed this hose laying in a pool of standing water on the floor in the production room, which could result in its contamination.

7. Failure to have plant construction and design that is suitable to facilitate maintenance and sanitary operations for food-manufacturing operations, including being constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair, as required by 21 CFR 110.20(b)(4). Specifically:

a. The floor in the ready-to-eat cheese production room was uneven, allowing water to pool on the floor during production instead of draining properly.

b. The cement floor around the firm’s floor drains was uneven and pitted, allowing water and debris to pool around the floor drains instead of draining properly.

8. Failure of plant management to take all reasonable measures and precautions to ensure that persons working in direct contact with food, food-contact surfaces, and food-packaging materials remove all unsecured jewelry that might fall into food, equipment, or containers, as required by 21 CFR 110.10(b)(4). On August 10, 2010, investigators observed food handlers wearing necklaces that dangled over ready-to-eat Queso Fresco as the food handlers leaned over the batch pasteurizer during production. These necklaces should be removed to ensure that they don’t fall into the food or equipment.

9. Failure of plant management to take all reasonable measures and precautions to ensure that persons working in direct contact with food, food-contact surfaces, and food-packaging materials wash their hands thoroughly and sanitize as necessary to prevent against contamination with undesirable microorganisms in an adequate hand-washing facility before starting work, as required by 21 CFR 110.10(b)(3). Specifically, on August 10, 2010:

a. Food handlers washed soiled utensils and equipment and then resumed the preparation of ready-to-eat Queso Fresco without first washing their hands and changing their gloves. Food handlers wore the soiled gloves while manually forming rounds of ready-to-eat Queso Fresco.

b. Food handlers placed clean disposable gloves on their hands without first washing their hands at the hand wash sink in the cheese production room.

10. Failure to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on August 10 and 11, 2010:

a. A live fly was flying throughout the firm’s ready-to-eat cheese production area and landed on several food contact surfaces, including the metal form used to shape ready-to-eat Queso Fresco. The metal form was not washed and sanitized after the fly landed on it and was subsequently used to produce additional rounds of ready-to-eat Queso Fresco.

b. The screening on the rear door of the firm, which opens to the outside, was torn, allowing pests entry into the firm’s processing area.

c. The rear lot directly outside of the rear door of the firm was filled with unused equipment and construction debris, creating a potential harborage site for rodents, insects, and other pests.

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