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WARNING LETTER

Dutch Farmstead Cheese MARCS-CMS 510106 —


Recipient:
Dutch Farmstead Cheese


United States

Issuing Office:
Dallas District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

 

November 07, 2016
 
2017-DAL-WL-02
 
 
WARNING LETTER
 
 
UPS OVERNIGHT
 
Teresa J. Mesman, Owner
Dutch Farmstead Cheese
542 County Road 7
Farwell, Texas 79325
 
Dear Ms. Mesman:
 
From July 11, 2016 through July 14, 2016, Investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your cheese processing facility, located at 542 County Road 7, Farwell, Texas 79325. During the inspection, the Investigators observed that you have serious violations of the Current Good Manufacturing Practice (GMP), In Manufacturing, Packing, or Holding Human Foods regulation (Title 21, Code of Federal Regulations, Part 110). Accordingly, we have determined that the ready to eat cheese manufactured by your firm is 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 the products were prepared, packed, or held under insanitary conditions whereby they may have become 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.
 
At the conclusion of the inspection, the Investigators issued your firm a FDA 483, Inspectional Observations, dated July 14, 2016. Your firm did not submit a written response to the observations documented on the FDA 483.
 
The specific violations observed during the inspection include the following:
 
1.    Your firm failed to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). For example:
 
a.  An employee was observed opening a drain valve on the bottom of the cheese vat. The whey inside the vat was discharged onto the floor covering the surrounding floor. This discharge then flowed approximately five feet across the floor to a drain in the northwest corner of the room. The discharge of whey onto the floor may provide nutrients for microbial growth in the pitted and cracked floor.
 
b.  The Investigators observed a plywood cover over the mixing vat in the production area. This cover was observed to have chipped edges with missing wood, chipping paint, and discolored by moisture. This plywood cover may be a source of bacterial contamination.
 
2.    Your firm failed to provide adequate screening or protection against pests, as required by 21 CFR 110.20(b)(7). During the inspection, multiple pest ingress points were identified. Measures employed by your firm are inadequate, as evidenced by the large numbers of flies observed throughout the facility, including in the packaging and production areas. The points of ingress observed include the following:
 
a.  The floor drain in the northwest corner of the production area is not adequately screened to prevent pests from gaining access to the food production area. Additionally, sunlight is visible in the drain when looking into the drain from the production area.
 
b.  The primary entrance door into your firm has an approximate 1 inch gap along the bottom of the door. This gap may provide sufficient space for pest ingress. Similarly, an approximate 1 inch gap was observed under the door that leads into the production area from the storage and packing area; the same room where the primary entrance door is located. Gaps in both doors were discussed during the FDA inspection that closed on 05/27/2015.
 
c.  Gaps in baseboards were observed in the production area and packaging room, providing a potential ingress point for pests. Additionally, damaged baseboards were observed in the packaging room where rodenticide bait blocks were scattered around the immediate area. The presence of bait blocks indicates a concern for rodents with the use of rodenticide as a means to control the hazard. According to 21 CFR 110.35(c), the use of insecticides or rodenticides is permitted only under precautions and restriction that will protect against the contamination of food, food-contact surfaces, and food-packaging material.
 
Additionally, there were multiple pest attractants and harborage locations noted on the exterior of your facility that increase the potential for pests to gain entrance into your firm. These attractants and harborage locations included:
 
a.  Adjacent to where drainage exits the production area through the floor drain, there is a large Polyvinyl Chloride (PVC) drain opening that transfers the drainage to a lagoon located on the property. This open drain, with access to a large body of water, is a pest attractant.
 
b.  Your firm is surrounded by cattle lots containing herds of cattle, which attract flies and other pests.
 
c.  High weeds on the exterior were observed immediately adjacent to the building, and present a potential harborage point.
 
3.    You failed to maintain your firm’s buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from being adulterated, as required by 21 CFR 110.35(a). Specifically:
 
a.  Floors in the production area and packaging area were observed pitted and cracked. During the inspection, the investigators noted that the pitted and cracked floors in the production area were holding fluid. In the areas of the pitted and cracked floors that were not holding fluids, a buildup of dirt was observed.
 
b.  A three basin sink is located in the production area, and is used for cleaning production equipment. The sink was not constructed with drain lines that discharge waste into a suitable drain. The sink drains waste directly onto the pitted and cracked production floor before flowing approximately five feet to the floor drain.
 
4.    Your food manufacturing facility is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 110.20(b)(4). Specifically, condensation was observed dripping from the cooling unit in the cheese aging room. A bucket was located under the dripping pipe to collect the condensate; however, condensate was also dripping onto the floor surrounding the bucket. Condensate dripping onto the pitted floor contributes to the risk of microbial contamination of finished food products.
 
5.    Your firm failed to establish a procedure for cleaning and sanitizing of equipment and utensils that provides adequate cleaning and sanitizing treatment, as required by 21 CFR 110.35(d)(5). For example:
 
a.  Your firm is not following the recommended concentration and temperature guidelines outlined on the (b)(4) cleaner labeling. Specifically, for the (b)(4) Cleaner, Mr. Mesman stated that temperature he used to circulate the (b)(4) cleaner is (b)(4)° F. However, the labeled directions for the (b)(4) cleaner indicate that it should be used at between (b)(4)° F - (b)(4) ° F. In addition, Mr. Mesman stated he used (b)(4) oz. (b)(4) per (b)(4) gallons water for the (b)(4) cleaner concentration.  However, the labeled directions for the (b)(4) cleaner indicate that it should be used at between (b)(4) oz - (b)(4) oz water for the(b)(4)  cleaner concentration. Lastly, you were observed to not be rinsing the system before and after use with potable water, as stated on the product label.
 
b.  Your process for cleaning wood boards, which are used to hold cheese products in the aging room, was documented as taking the boards to a (b)(4) for cleaning. Cleaning food contact surfaces at a (b)(4) may introduce microbial, chemical, and physical hazards that are outside of your control and can result in adulterated and contaminated food product.
 
6.    You failed to ensure employees wash and sanitize their hands thoroughly in an adequate handwashing facility before starting work, after each absence from the work station, and at any time their hands many have become soiled or contaminated, as required by 21 CFR110.10(b)(3). Throughout the inspection, your employee was observed moving between the production area, the packaging room, and the ageing room, touching doors between each room, without stopping to wash their hands. Your employee was also observed touching non-food contact valves and utensils without washing their hands prior to handling in process and finished cheese products.
 
7.    You failed to ensure all persons working in direct contact with food, food-contact- surfaces, and food-packaging materials conformed to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 110(b)(1). Specifically, your employee was observed wearing garments while manufacturing and packing cheese that were also worn while working in the surrounding cattle lots earlier in the day. These garments included shoes, shirt, shorts, and hat. Wearing the same garments in the cattle lots as you would in the food production area may introduce pathogenic microbial contaminants to the food production environment.
 
The above list is not intended to be an all-inclusive list of violations 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 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 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.
 
You should notify this office in writing within fifteen business days from your receipt of this letter of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled processes have been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies. 
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Acting District Director, 4040 N. Central Expressway, Suite 300, Dallas Texas, 75204. If you have questions regarding any issues in this letter, please contact Chad J. Whitwell at 214-253-5328.
 
 
Sincerely,
/S/ 
Karlton T. Watson
Acting Dallas District Director
 
 
Cc:     
Berny W. Mesman, Co-Owner.
Dutch Farmstead Cheese
542 County Road 7
Farwell, Texas 79325
 
Lori Woznicki, Food and Drug Inspections Branch Manager
Division of Regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756