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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Finger Lakes Farmstead Cheese Company LLC 10/23/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

New York District         
158-15 Liberty Avenue
Jamaica, NY 11433 
 

 

October 23, 2012

WARNING LETTER NYK-2013-1


VIA UNITED PARCEL SERVICE OVERNIGHT MAIL

Nancy Taber Richards, Co-owner
Finger Lakes Farmstead Cheese Company LLC
5491 Bergen Road
Trumansburg, New York 14886-9674

Dear Ms. Taber Richards:

The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility located at 5491 Trumansburg, New York from June 5 - 21, 2012, and again from July 9 - 12, 2012.  On June 5, 2012, FDA collected environmental samples from multiple areas in your processing facility.  FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen.  In addition, during the July inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110].  These 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 contaminated with filth, or  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.

On June 19, 2012, FDA also collected finished product sample 760809 of your Bianco Brie-style Cheese.  Laboratory analyses confirmed the presence of Listeria monocytogenes rendering the cheese adulterated within the meaning of section 402(a)(1) [21 U.S.C. § 342(a)(1)] of the Act, in that it contains a poisonous or deleterious substance which may render it injurious to health.  We acknowledge your statement that you did not distribute this lot of Bianco Brie-Style Cheese, and that the affected product was destroyed.

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.

Five environmental swabs collected on June 5, 2012 from your facility tested positive for L. monocytogenes.  These swabs were collected from: inside of a brine tank (right side); cheese rack in the aging cooler; cheese board in the aging cooler; outside of a brine tank (left side); and a processing room floor drain.

Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that the L. monocytogenes isolates obtained from the FDA environmental samples collected on June 5, 2012, 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. 

On June 19, 2012, the FDA informed your firm of the environmental sampling results.  Your firm indicated that you would stop production to clean and sanitize your facility.  During the July 2012 inspection of your facility, an FDA investigator observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:

1. You failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d).  You failed to clean and sanitize all of the wooden boards used to hold your Gouda-style cheese in the large aging cave even after FDA informed you of positive L. monocytogenes results found on one of these boards.

2. You failed to clean non-food contact surfaces of your facility as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d)(3).  You failed to clean any of the metal racks in the large aging cave used to hold the wooden boards (used to hold cheese) even after FDA informed you of positive L. monocytogenes results found on one of these racks.

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 applicable regulations.  Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice.  For example, we may take further action to seize your products and/or enjoin your firm from operating.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter.  Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made. 

In addition to the charges above, we have the following comments:

• On June 19, 2012, FDA also collected finished product sample 758101 of your Schuyler Gouda Cheese.  FDA Laboratory analyses of that sample found high levels (sub #1 = 150 MPN/g, sub #2 = 93 MPN/g) of generic Escherichia coli (E. coli). Generic E. coli is an indicator of fecal contamination; its presence suggests that your sanitation practices may be inadequate.  We acknowledge that you initiated a voluntary recall of all three varieties of Gouda cheese you produced on the same day as the Schuyler Gouda that FDA sampled.

• Please be advised that FDA has issued draft guidance entitled Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance.  You may submit comments on this draft guidance to the agency as outlined in the document.  We have enclosed a copy of the draft guidance for your information, and it is available online at: http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm

• You may wish to take further safety measures, including but not limited to focusing on animal health, hygienic milk collection and storage, and microbiological criteria (i.e. a maximum acceptable concentration of coliform bacteria).  Further, you may wish to contract with an expert to assist you with implementing a program to eliminate and prevent further product contamination with organisms that pose threat to the public health.

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 2012 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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202.  If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or E-mail at dean.rugnetta@fda.hhs.gov.

Sincerely,

/S/

Ronald M. Pace
District Director
New York District

 

cc:  Jan Beuzekom, Co-owner
      Finger Lakes Farmstead Cheese Company LLC
      5491 Bergen Road
      Trumansburg, New York 14886-9674


cc:  Casey McCue
      State of New York
      Department of Agriculture and Markets
      Division of Milk Control and Dairy Services
      10B Airline Drive
      Albany, NY 12235