Mr. John A. Celauro,
- 4 C Foods, Corp.
580 Fountain Avenue
Brooklyn, NY 11208-6002
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
August 18, 2015
WARNING LETTER NYK-2015-49
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. John A. Celauro, President
4C Foods, Corp.
580 Fountain Avenue
Brooklyn, NY 11208-6002
Dear Mr. Celauro:
The United States Food and Drug Administration (FDA) inspected your cheese manufacturing facility located at 580 Fountain Avenue, Brooklyn, NY on October 9-15, 2014, and November 13-24, 2014. During the October 2014 inspection, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analyses of the environmental swabs (Sample #765895) found the presence of Salmonella
, a human pathogen. In addition, during the November 2014 inspection, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations and our findings of Salmonella
in your processing facility cause your ready-to-eat cheese products to be adulterated within 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 rendered injurious to health. You can find the Act and the CGMP regulations for foods through links on FDA’s home page at www.fda.gov
Presence of Salmonella
Salmonella is a pathogenic bacterium that is tolerant to desiccation, and is therefore capable of surviving in a dry environment or product. This enables the pathogen to colonize and persist in processing environments and thus contribute to the lingering presence of this pathogen in food contact surfaces and environments that are not kept in a sanitary condition. As a result, the likelihood of the pathogen’s survival and subsequent contamination of food is increased and, thus, poses a potential health hazard to consumers when they consume foods contaminated with Salmonella. Consuming these contaminated foods can lead to foodborne illness, which is a public health concern.
On July 22, 2014, FDA collected a finished product sample of your ‘4C Homestyle Grated Parmesan Cheese’ (Sample #827173) that was analyzed and tested positive for Salmonella. Furthermore, during FDA’s October 2014 inspection, FDA collected 100 environmental swabs from your cheese and bread production areas, of which twelve (12) environmental swabs collected from zones 1, 2, and 3 in the cheese grating room were found positive for Salmonella. Three (3) of these environmental swabs were collected from food contact surfaces (i.e., zone 1 regions) including, the shaker plug inserter, cheese filling hopper #18 at the finished product discharge point, and gasket on cheese dryer. The presence of Salmonella in your processing facility, especially on food contact surfaces, could lead to cross contamination and transmission of Salmonella to your finished product, which may subsequently cause illness to humans if such product is consumed.
In addition, a Whole Genome Sequence (WGS) analysis revealed that the Salmonella Infantis isolated from the parmesan cheese sample collected on July 22, 2014, is related to the Salmonella Infantis isolated from eleven (11) of the environmental samples collected during the October 2014 inspection, suggesting that Salmonella has been persistent in the facility, and confirms your inability to ensure an adequate sanitary environment and conditions for cheese manufacturing.
Although your firm provided a corrective action plan in response to the positive environmental findings, you did not identify the source of Salmonella in your plan. To prevent future contamination of the environment and finished product with the pathogen, the source needs to be identified and eliminated. We will verify the adequacy of your corrective action at a follow-up inspection.
FDA’s guidance, “Guidance for Industry: Testing for Salmonella
Species in Human Foods and Direct-Human-Contact Animal Foods” addresses testing procedures for Salmonella species in human foods and is available at www.FDA.gov
at the following link:
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110):
1. You did not take effective measures to exclude pests from the processing areas, as required by 21 CFR 110.35(c). Specifically, on November 13, 2014, an FDA investigator observed one live apparent rodent walking along a beam attached to the ceiling adjacent to the bread crumb packaging line during manufacturing operations.
We acknowledge your response dated November 26, 2014; however, your response did not include any records, such as correspondence with the pest control provider, demonstrating additional pest control efforts. In addition, your response does not indicate a sanitation supervisor, after termination of the individual holding that position. The adequacy of your reported corrective actions will be verified during a follow-up inspection.
2. You did not take necessary precautions to protect against contamination of food, food contact surfaces and food packaging systems with microorganisms, as required by 21 CFR 110.10(b)(9). Specifically, during the FDA inspection on November 13, 2014, employees were observed entering and exiting the restrooms and break rooms without removing and reapplying production uniforms. During the inspection, your firm’s personnel stated employees were not required to “de-gown” while using the restroom or while in the break room, only when leaving the facility and that uniforms are washed once per week.
We acknowledge your response dated November 26, 2014, that states coveralls should be removed when going to the restroom or break room and that “proper standards for employee cleanliness, including the proper use of outer garments, will be incorporated into regular employee GMP training.” The adequacy of your reported corrective actions will be verified during a follow-up inspection.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should 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 deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. 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.
Further, 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. Re-inspection-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 inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your firm’s written response should be sent the Food and Drug Administration; Attention:
LCDR Catherine M. Beer
U. S. Food and Drug Administration
One Winners Circle, Suite 110
Albany, NY 12205
If you have any questions about the content of this letter please contact: LCDR Beer at (518) 453-2314 x1015.
Ronald M. Pace
New York District
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