Inspections, Compliance, Enforcement, and Criminal Investigations
Mongiello Italian Cheese Specialties, Inc. dba Formaggio 1/23/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
WARNING LETTER NYK-2014-17
January 23, 2014
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Anthony Mongiello, CEO & Owner
Mongiello Italian Cheese Specialties, Inc. d.b.a. Formaggio
250 Hilldale Road
Hurleyville, NY 12747
Dear Mr. Mongiello:
On July 22, 24, 26, and August 13, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your cheese processing facility located at 250 Hilldale Road, Hurleyville, New York. The inspection was initiated in response to notification from the United States Department of Agriculture Food Safety Inspection Service (“USDA FSIS”) regarding finished product and environmental samples containing Listeria monocytogenes (“L. monocytogenes”). During the FDA inspection, investigators documented significant observations of insanitary conditions in violation of FDA’s Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations, Title 21 of the Code of Federal Regulations Part 110 (21 CFR Part 110). Moreover, an analysis of environmental swabs collected at your facility during the FDA inspection under sample number 817806 found the pathogen L. monocytogenes in [ b(4) ] locations at your facility. The conditions observed by our investigators and the finding of L. monocytogenes cause the cheese processed at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.§ 342(a)(4)], in that your cheese has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov. Additionally, you may find our draft guidance for the control of L. monocytogenes by following links for industry guidance and Listeria at www.fda.gov.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Consumption of food contaminated with L. monocytogenes can result in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Listeriosis is an atypical food borne 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. Listeriosis in pregnant women is typically a mild “flu-like” illness, but can result in fetal death, premature labor, or neonatal infection.
A 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 may be conducive to pathogen growth in your products.
Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that the L. monocytogenes isolates obtained from the FDA environmental samples collected on July 22, 2013 and the finished products and environmental samples collected by the USDA FSIS (collected between April and July 2013) were indistinguishable from each other by both a primary and secondary enzyme. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and established niche areas.
The following conditions were noted during the inspection of your facility:
1) Failure to maintain plant construction in such a manner that drip and condensate do not contaminate food and food contact surfaces, as required by 21 CFR § 110.20(b)(4).
Specifically, on July 22 and 24, 2013, condensation was present and a water like substance was dripping from the ceiling and pipes in the facility production areas in the following locations:
a) Water like substance was dripping from a green stained part of the ceiling in the Curd Cutting Room near an open transportable vat of cheese curd;
b) Water like substance noted dripping off a pipe, used to transport (b)(4), over an open transportable vat of (b)(4) product in the Cup Packaging Room. Condensation was also collecting on this same pipe above the filling machine;
c) Condensation noted collecting on various areas of the ceiling in the Cheese Production Room, which contains numerous open vats with cheese product in various stages of production;
d) Water like substance was dripping off a light fixture in the Mozzarella Cooler onto the floor in the vicinity of unwrapped, exposed product trays. Additionally, condensation noted collecting on a plastic pipe above exposed (b)(4) blocks of mozzarella cheese in the same cooler; and
2) Failure to take necessary precautions to protect against contamination of food and food-contact surfaces by foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin, as required by 21 CFR § 110.10(b)(9) in that on July 24, 2013, our investigator observed food handlers wearing sleeve arms that did not stay intact while dipping their arms into vats containing cheese curds and cheese products. The sleeve arms, which had been in contact with food handlers’ perspiration, skin, and hair, came in direct contact with ready-to-eat food products and food contact surfaces.
3) Employees did not sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station, as required by 21 CFR § 110.10(b)(3). For example, on July 24, 2013, our investigator observed an employee not sanitizing his hands after leaving and re-entering the Curd Cutting Room.
4) Failure to equip your plant with adequate sanitary facilities and accommodations including, but not limited to, plumbing of adequate design 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). For example,
a) On July 24, 2013, an open hose head at molding station (b)(4) was observed in contact with food like residues on the side of the molding machine. This hose is used to clean equipment; and
b) On July 24, 2013, a water spout in the Cheese Production Room was observed to be leaking from both sides of the shut off valve and from the pipe itself. This water spout is used to fill various vats that transport cheese product or brine solutions.
5) Failure to provide adequate screening or other protection against pests, as required by 21 CFR § 110.20(b)(7). For example, on July 24, 2013, gaps were observed below the following doors throughout the processing facility that lead directly outside the facility creating an entryway for pests into your production facility:
a. An approximate (b)(4) gap was observed in the bathroom hallway. This door leads directly outside and provides a direct entry for pests into the processing facility.
b. An approximate (b)(4) gap was observed in the left corner of the overhead bay door located to the (b)(4) in the dry goods storage dock. This door leads directly outside and provides a direct entry for pests into the processing facility.
c. Multiple various size gaps were observed under the overhead bay door located to the (b)(4) in the dry goods storage dock. This door leads directly outside and provides a direct entry for pests into the processing facility.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should notify this office in writing, within 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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The July 2013 inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to LCDR Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Kristen Jackson at (718) 662-5711 or E-mail at firstname.lastname@example.org.
New York District