Mexicali Cheese Corp. 10/27/10

October 27, 2010

WARNING LETTER NYK-2011-04

VIA UPS

Edinson Vergara
President
Mexicali Cheese Corp.
91-52 87th Street
Woodhaven, NY 11421-2948

Dear Mr. Vergara:

On August 10, 11 & 17, 2010, the Food and Drug Administration (FDA) conducted an inspection of your cheese processing facility located at 91-52 87th Street, Woodhaven, New York. The inspection was initiated in response to a notification from the New York State Department of Agriculture and Markets (NYSDAM) of elevated levels of Staphylococcus aureus found in a NYSDAM sample of your Queso Cotija Cheese product, which resulted in a consumer alert and recall on August 6, 2010. FDA analysis of environmental swabs collected at your facility during the inspection found the pathogen Listeria monocytogenes (L. monocytogenes) in five locations at your facility. The FDA inspection also revealed serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 - FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations. Both the violations observed by our investigators during the inspection and the finding of L. monocytogenes at your facility cause the cheese products processed at your facility to be adulterated within the meaning of Section 402(a)(4) ofthe Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.§ 342(a)(4)], in that the products 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. You can find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.

L. monocytogenes is a pathogenic bacterium that is widespread in the environment and maybe introduced into a food processing facility. L. monocytogenes can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Listeriosis is an atypical foodborne illness of major public health concern because of the severity of the disease, a high case-fatality rate, a long incubation, and a predilection for high-risk groups such as unborn babies, newborns, and those with impaired immune systems.

L. monocytogenes can be isolated from soil, silage, and other environmental sources and can also be found in man-made environments such as food processing establishments. Any moist area, such as your cheese production area, can harbor L. monocytogenes. This organism can grow at refrigeration temperatures. During our inspection, we documented conditions and practices that may lead to the contamination of your products with pathogens such as L. monocytogenes and maybe conducive to pathogen growth in your products. On September 8, 2010, FDA investigators visited you to relay the analytical findings of L. monocytogenes at your firm; during that visit, no change was observed from the violations previously discussed with you and noted on the form FDA483 issued on August 17, 2010.

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.

The above violations are not meant to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all of your products are in compliance with applicable laws and regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

You should notify this office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.

Your reply should be sent to Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. Attention: Lillian C. Aveta, Compliance Officer. If you have questions regarding this letter, please contact Ms. Aveta at (718) 662-5576.

Sincerely,

/s/

Ronald M. Pace
District Director
New York District

Enclosure: Form FDA 483 dated August 17, 2010