- Farmo Foods, Inc.
- Issuing Office:
- San Francisco District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
November 18, 2015
VIA NITED PARCEL SERVICE
Farhad Farr Hariri, President
Farmo Foods, Inc. dba Belfiore Cheese
2031 2nd Street
Berkeley, CA 94710-1906
Dear Mr. Hariri:
The United States Food and Drug Administration (FDA) inspected your cheese manufacturing facility, Farmo Foods, Inc. dba Belfiore Cheese, located at 2031 2nd
Street, Berkeley, CA on May 12 through May 28, 2015. During our inspection, FDA investigators collected an environmental sample consisting of multiple swabs taken from various areas within your processing facility. FDA laboratory analyses of the environmental swabs found the presence of a human pathogen Listeria monocytogenes
) in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we have determined that your food products are 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 FDA’s regulations through links on FDA’s home page at http://www.fda.gov
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s June 2, 2015, response to the FDA-483, which includes a description of corrections to the observations of concern noted on the FDA-483. However, your response does not provide comprehensive information to ensure the adequacy of your corrective actions in addressing the violations observed during the inspection. After review of the inspectional findings and your firm’s response, your firm’s significant deviations remain as follows:
FDA laboratory analysis of the environmental sample collected on May 14, 2015, confirmed that one (1) of the one hundred and one (101) environmental swabs was positive for L. monocytogenes. The positive swab was collected from the floor by the doorway between the Processing Room and the Packaging Room where your ricotta/ whey mixture is held. The presence of L. monocytogenes in your facility demonstrates that your sanitation efforts are inadequate to effectively control pathogens in your facility.
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.
Additionally, FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. Your firm failed to handle and maintain equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food in a manner that protects against contamination during manufacturing or storage, as required by 21 CFR 110.80(b)(7). Specifically, we observed pails, which are used to directly scoop Ricotta out of your vats, that were placed on the wet production room floor, where L. monocytogenes was isolated, then the pails were observed sitting in the ricotta/ whey mixture.
2. Your firm failed to take effective measures to exclude pests from the processing area, as required by 21 CFR 110.35(c). Specifically, our investigators observed rodent excreta pellets throughout your facility including on the floor and along the walls of your chemical room which leads directly into your processing area while you were processing mozzarella and ricotta cheeses, areas directly below your pasteurizer in the processing room, on the floor near your second floor storage area, and in gaps approximately ¼ inch in size through the wall separating the storage room from your labeling room. In addition, your pest control company has been reporting the recurrent pest and structural defects since September 2014.
3. Your firm failed to maintain buildings and physical facilities in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically, our investigators observed peeling paint and caulking on the ceiling directly above open ricotta tanks; damaged, cracked, and pitted floors in your processing room, ricotta room, brine room, and new packaging rooms; open and oxidized electrical wiring and pipes on the north wall of the brine room; holes in the wall and disconnected exhaust pipes in the chemical room in close proximity to one observed pile of rodent feces; damaged flashing exposing stains and crevices in the packaging room, stained and unclean walls in the label room, and holes on the west wall of the processing room. These facility disrepairs were pointed out to you by the California Department of Agriculture by way of Notices of Violations issued to you in June 2014, December 2014, and March 2015.
4. Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, you store your ready-to-use packaging materials with scrap metal, building construction materials, used plastic pails, and woven plastic bags containing wood chips in open trailers permanently attached to your loading dock; and obsolete office files and equipment, obsolete production equipment, used and discarded plastic pails, cartons, scrap metal, and other scrap material was seen stored in your second floor storage area where rodent feces was found.
5. Your firm failed to provide had washing and hand sanitizing facilities at each location in the plant where needed, as required by 21 CFR 110.37(e)(1). Specifically, there is no hand washing facilities in the production areas, or along the route taken by employees as they begin their work day.
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.
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) 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.
Please send your reply to the Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issues in this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.
Kathleen M. Lewis, J.D.
San Francisco District