Dear Mr. Berliant,
During August 16 through September 7, 2011, the U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility located at 1458 W. Grand River Avenue, Williamston, MI 48895. During the inspection, FDA collected one environmental sample consisting of 118 swabs of food contact and non-food contact surfaces. FDA laboratory analyses of this sample confirmed the presence of Listeria monocytogenes in 26 swabs. In addition, FDA investigators observed significant violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations and the presence of Listeria monocytogenes in your manufacturing facility cause the foods manufactured at your facility to be 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. You can find the Act and FDA's regulations through links on FDA's home page at .
Listeria monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodbourne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
On September 22, 2011, we called your firm to advise you that our testing had resulted in isolation of Listeria monocytogenes from 26 swabs. We acknowledge that during this conversation, your firm committed to voluntarily destroy the (b)(4) cases of Whole Grain 3 Cheese Boat (With Garlic Sauce & Cheese Blend) that were manufactured in your facility while FDA personnel collected the environmental swabs on August 24, 2011. However, based on the presence of Listeria monocytogenes in your facility and the violations discussed below, it is apparent that your firm operates under insanitary conditions.
During the inspection, FDA investigators observed the following significant CGMP violations:
1. You failed to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically:
a. A mold-like growth was observed in the following areas: on the ceiling and interior wall of the packaging room approximately 5 feet from the product conveyor, in the spiral freezer within 3 feet of the product conveyor, and in the storage freezer along the joints and corners.
b. Forty-two of (b)(4) lots of frozen food products in the west portion of the storage freezer were observed with mold-like growth. Some of the food items noted with this mold-like growth included: Three Cheese Pizza; Bologna and Cheese on Whole Wheat Kaiser; Chef Burry Cheese Pizza Bagel; Chicken Biscuit Sandwich; and 12" Pizza Shell.
We acknowledge that during our inspection, your firm provided a letter of voluntary destruction and a list of products destroyed, and informed us that maintenance and cleaning were performed in areas where mold was observed. We will verify these corrections during our next inspection.
2. You failed to construct the plant and facilities in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food packaging materials, as required by 21 CFR 110.20(b)(4). Specifically:
a. After a rain fall, water droplets were observed on the ceiling and running down a wall above the entrance to the spiral freezer in the North West corner of the packaging room.
b. Water was observed dripping from the ceiling, running down a wall, and dripping through the conveyor belt at the entrance of the spiral freezer.
c. Water droplets were observed inside the spiral freezer on the north wall where the conveyor carries product through an opening in the wall. Whole Grain Reduced Fat Texas Cheese Toast, lot# 11231, was observed being manufactured on this same conveyor equipment, and according to your firm's management, this equipment was not cleaned prior to production.
3. You failed to construct the plant and facilities in such a manner that floors, walls, and ceilings may be kept in good repair, as required by 21 CFR 110.20(b)(4). Specifically:
a. Multiple cracks were observed on interior walls of the production room along the floor/curb juncture and at seams, and in the packaging room along the vertical seams and at the floor/wall juncture.
b. The concrete floor was observed to be pitted and cracked throughout the facility.
4. You failed to maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition, as required by 21 CFR 110.10(b)(5). Specifically, employees were observed touching the control switch of the cheese shredder machine and then picking up blocks of cheese with the same gloved hands and placing them into the shredding machine with no cleaning or sanitizing of the gloves between jobs.
5. You failed to conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically, your employees were observed using a pressurized water hose to rinse off in-use equipment. The water from the hose was observed contacting the floor and equipment, and aerosolizing in the room during the manufacture of Whole Grain Three Cheese Boat, lot #11236.
a. An employee was observed spraying down the corner conveyor piece approximately 10 feet from the conveyor during production down time.
b. An employee was observed spraying down the floor approximately 15 feet from the sauce depositor and conveyor during production of Whole Grain Three Cheese Boat, lot #11236.
6. Your equipment and utensils must be designed and of such material and workmanship as to be adequately cleanable and must be properly maintained, as required by 21 CFR 11 0.40(a). However, your cleaned equipment in the processing room was designed and maintained in a manner allowing for accumulation of soils. Specifically:
a. Rough welding was observed on the curved metal piping of the interior food-contact surface of the basin for the sauce depositor, and an accumulation of soil was observed on this welding.
b. Rough welding was observed on a repaired corner of the interior food-contact surface of the basin. This basin is routinely used to manufacture products containing sauce bases, and was used for the manufacture of Whole Grain Texas Cheese Toast, lot #11231 and Whole Grain Three Cheese Boat, lot #11236.
7. You failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically:
a. The overhead door located in the southwest corner of the mechanical room was observed with a gap approximately 2 inches by 8 inches on the upper left corner of the weather-stripping.
b. The overhead door at the truck dock was observed with an approximate 1 inch gap around the outside edges.
c. Live mosquitoes were observed in the common area, in front of the storage freezer door which opens into the processing and packaging rooms, and in the mechanical room.
The above violations are not meant to be an all-inclusive list of violations that may exist at your facility or with respect to your products. It is your responsibility to assure that your facility and your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to implement procedures to prevent such violations from recurring. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Please also include documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.