Inspections, Compliance, Enforcement, and Criminal Investigations
Gioia Cheese Company Inc. 1/23/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
January 23, 2013
Mr. Vito Girardi, President and Owner
Gioia Cheese Co., Inc.
1605 Potrero Ave.
South El Monte, CA 91733-3018
Gioia Cheese Co., Inc.
1605 Potrero Ave.
South El Monte, CA 91733-3018
Dear Mr. Girardi:
The U.S. Food and Drug Administration (FDA) inspected your cheese manufacturing facility, located at 1605 Potrero Ave., South El Monte, CA 91733-3018, from August 22 through 29, 2012. During our inspection, FDA collected environmental samples from multiple areas in your processing facility as well as ricotta cheese product samples. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen. In addition, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These CGMP violations and our findings of L. monocytogenes in your processing facility cause your ready-to-eat cheese products 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 been rendered injurious to health. You can find the Act and the CGMP regulation for foods through links in FDA’s home page at www.fda.gov.
L. 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 foodborne 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.
Laboratory findings from the August 2012 inspection represent the third time since 2010 that FDA has detected L. monocytogenes at your facility. Two environmental swabs collected from your facility in July 2010 and five environmental swabs collected in February 2011 tested positive for L. monocytogenes. The July 2010 swabs testing positive for L. monocytogenes were collected from the floor around the floor drain underneath the brine tank and the floor around the wheel of the brine tank. Swabs collected in February 2011 from your facility testing positive for L. monocytogenes were collected from the floor directly underneath soak tank # 2 in the southeast corner of the main processing room, the floor underneath the weighing table located on the southeast side of the main processing room, the surface of the floor drain located directly underneath the brine tank on the southeast side of the main processing room, the floor and under surface of the floor mat placed underneath the weighing table in the southeast corner of the main processing room, and the underneath surface of a white plastic bucket placed directly under the weighing table in the main processing room near the south wall.
Adding to the past findings of L. monocytogenes at your facility, three swabs collected in August 2012 from your facility tested positive for L. monocytogenes. These swabs were collected from the wheels and west side of mozzarella holding table located near a drain, underneath the north drain grate, and the floor mat near the packing table.
Pulsed-field gel electrophoresis (PFGE) testing results determined that the two environmental swabs from July 2010 and the five environmental swabs from February 2011 had a PFGE pattern that was indistinguishable from the three positive environmental swabs collected in August 2012. The PFGE results suggest that L. monocytogenes may have been transported throughout your facility and may have established niche areas to colonize. The presence of persistent L. monocytogenes in your facility over time is significant in that it demonstrates that your sanitation efforts are inadequate to effectively control pathogens in your facility and prevent the contamination of food. Once established in a production area, humans or machinery can facilitate the pathogen’s movement to and contamination of food-contact surfaces and finished product.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. You firm failed to handle work-in-progress in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5).
Specifically, an employee was observed to be spraying water with a high-pressure hose onto the floor and into a drain in the pasteurization room in close proximity to a rack holding in-process, exposed ricotta cheese.
2. Your firm failed to handle and maintain equipment, containers, and utensils used to convey, hold, or store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7).
Specifically, an employee was observed holding a bucket of stretched mozzarella with his/her bare arms in direct contact with the outer surface of the bucket. Subsequently, the bucket was dipped directly into a cooling table and used to transfer water to another cooling table containing mozzarella.
3. Your firm failed to adequately install and maintain plumbing so that it is not a source of contamination to water supplies, as required by 21 CFR 110.37(b)(3).
Specifically, a discharge hose was observed to be submerged under water in a cooling table containing in-process mozzarella. To prevent contamination of in-process food and to protect your water supply against backflow and backsiphonage, your firm must install a backflow prevention device on the hose and/or water line. You must also take steps to ensure that the discharge hose is no longer submerged in or otherwise in contact with the water in the cooling table in a manner that can allow for cross-contamination to food.
We acknowledge receipt of your letter dated October 1, 2012, in response to FDA’s positive L. monocytogenes environmental swabs. Your letter indicates that you are currently updating your food defense practices to include a comprehensive L. monocytogenes testing program and that you are working closely with a food safety company with dairy and sanitation expertise. Your letter also indicates that you are implementing an environmental program that will include weekly monitoring for L. monocytogenes. Your response does not address the CGMP deviations identified in this letter.
In updating your food defense practices, it is essential to identify all areas of your facility where L. monocytogenes is able to grow and survive (niche areas) and to take such corrective actions as necessary to control the organism. We note that a second, nonpathogenic species of Listeria, L. seeligeri, was found in your cheese products that were sampled in 2009 and again during the August 2012 inspection. These findings further demonstrate that your cheese products are manufactured under conditions that may reasonably allow food to be contaminated with Listeria species, including pathogens. As such, FDA recommends that your sanitation controls include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination.
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. Your firm should take prompt action to correct the violations addressed in this letter and to implement procedures to prevent such violations from recurring. Failure to do so may result in enforcement action by FDA without further notice, including seizure and injunction.
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 reinspection 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 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.
Please respond in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken, including details about the corrections noted in your October 1, 2012 response letter. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Please send your response to Mr. Blake Bevill, Director, Compliance Branch, Food and Drug Administration, Los Angeles District Office. Refer to the Unique Identification Number, CMS case # 362078, when replying. If you have any questions about the contents of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or email@example.com.
Alonza E. Cruse, Director
Los Angeles District
Cc: Patrick Kennelly, Acting Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue – MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413