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  5. Taylor Farm, Inc. - 526184 - 08/30/2017
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WARNING LETTER

Taylor Farm, Inc. MARCS-CMS 526184 —

Delivery Method:
UPS
Recipient:
Recipient Name
Mr. Jonathan H. Wright
Taylor Farm, Inc.

825 Route 11
Londonderry, VT 05148
United States

Issuing Office:
New York District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations East - Division 1 

 
 

 

WARNING LETTER
CMS # 526184
 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
August 30, 2017 
 
 
Mr. Jonathan H. Wright, Owner
Taylor Farm, Inc.
825 Route 11
Londonderry, VT 05148
 
 
Dear Mr. Wright:
 
The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility located at 825 Route 11, Londonderry, VT 05148, on April 18 to April 21, 2017. During the inspection FDA investigators observed serious violations of the FDA’s Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).1 These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (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 rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
 
The serious CGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations (FDA-483), issued to you at the close of the inspection. Those violations include the following:
 
1.    ­Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR Part 110.80(b)(1). Specifically, investigators observed:
  • Metal storage racks in the drying/brine tank room had apparent rust and were stored in close proximity to exposed cheese wheels. Furthermore, the exposed surface of cheese wheels aging on the metal storage racks was observed covered with rust flakes from the racks above the cheese. 
  • A storage container with apparent dirt and filth on the outside surface was stored directly above exposed cheese in the drying/brine room.  
Additionally, FDA isolated non-pathogenic Listeria species, including L. innocua from two (2) of one hundred five (105) environmental swabs (Sample 977359).  Environmental swab #84 was collected from the rusting underside front edge of your metal cheese aging racks in the drying/brine tank room.  The other swab (#25) is addressed below. The presence of non-pathogenic Listeria species is indicative of conditions that are suitable for the survival and/or growth of pathogenic Listeria monocytogenes.
 
2.    Failure to maintain buildings, fixtures, and other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). Specifically, investigators observed water pooling on the floor of the drying/brine tank room. Environmental swab #25 (Sample 977359) collected from this area of water pooling on the floor of the drying/brine tank room confirmed the presence of Listeria innocua. The presence of non-pathogenic Listeria species, including Listeria innocua, is indicative of conditions that are suitable for survival and/or growth of pathogenic Listeria monocytogenes.
 
3.    Failure to take effective measures to exclude pests from the processing areas, as required by 21 CFR Part 110.35(c). Specifically, investigators observed:
  • Apparent insect webbing in the left corner of the drying/brine tank room and aging room adjacent to the cooler system where exposed cheese wheels were stored.
  • Three apparent rodent excreta pellets on a cloth sheet covering the cheese vat in the receiving room.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure. 
 
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 re-inspection-related costs. A re-inspection 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 re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
 
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, 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 15 working days, 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. 
 
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at scott.loughan@fda.hhs.gov.
 
 
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1
 
­­­_______________________
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[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.   See http://www.fda.gov/Food/GuidanceRegulation/ FSMA/ ucm334115. htm#Compliance_Dates for PC rule compliance dates.

 

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