- Farm Country Cheese House, Inc
- Issuing Office:
- Detroit District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
December 4, 2015
Mr. Jim Nunley, Owner
Farm Country Cheese House, Inc.
6263 Kendaville Road
Lakeview, MI 48850-9563
Dear Mr. Nunley:
The U.S. Food and Drug Administration (FDA) inspected your cheese manufacturing facility located at 6263 Kendaville Road, Lakeview, MI 48850 on October 13-23, 2015. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These GMP violations render the ready to eat cheeses manufactured by your firm 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 have been 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, the CGMP regulation for foods through links in FDA's home page at www.fda.gov
We acknowledge your written response received on November 13, 2015, to the Form FDA-483, Inspectional Observations, issued to your firm on October 23, 2015. Your corrective actions are addressed below in relation to each of the noted violations. The October inspection was a follow-up to previous inspection that concluded on January 23, 2015. The January 2015 FDA inspection found significant CGMP violations.
The following significant CGMP violations were continued and documented during the current inspection:
Processes and Controls:
1. You failed to take reasonable precautions to ensure that production procedures do not contribute contamination from any source as required by 21 CFR 110.80. For example:
a. On October 13, 2015, during production of Stirred Curd Cheddar cheese in Vat (b)(4) the overhead mixing channel on the SE end of Vat (b)(4) was damaged and cracked. It was observed that when the mixing rotor travels to the damaged and cracked end, the junction area moves, it allows for particles to come off the unit. This is directly above exposed curds and whey in the vat.
b. On October 13, 2015, we observed in-use cheese rakes and a cheese cutting apparatus stored against the north wall.
c. On October 13 and 14, 2015, we observed white brushes (used for cleaning post-pasteurization food contact surfaces) stored on the wall approximately 2 feet from the make room hand-sink. The sink's drain discharged to the wall and onto the floor. Splash from the sink can contaminate the white brushes which are not washed prior to use. This was a repeat observation from the December 2014 and January 2015 inspections.
d. On October 14, 2015, we observed the storage of hoop pins on the gear housing of cheese press (b)(4), which is rusted with chipping paint; it is not an easily-cleanable food contact surface. The pins are food contact surfaces used when the cheese curds are loaded into the hoop box. Monterey Jack cheese was produced on October 14, 2015 in Vats (b)(4).
e. Your firms food contact surface swabbing results revealed multiple instances where APC counts were greater than 50 colonies per ml (the action limit identified by your laboratory), which indicates improper cleaning and sanitization. No corrective actions were taken to remediate the results. For example: on June 9, 2015, cheese hoops (b)(4) were swabbed and found APC (Aerobic Plate Counts) results TNTC (Too Numerous To Count); on July 2, 2015, curd knife was swabbed and found 110 APC/ml and 63 APC/ml; and then again on August 18, 2015, curd knife results were 2000 APC/ml and 56 APC/ml.
In your written response, you explain that your firm plans to repair the track by the end of the month; however, the repair date has not been scheduled or another suggested corrective action was not provided to prevent contamination, until repair can be completed. You plan to repair the exhaust fan by cutting a hole in the ceiling and rerouting the exhaust pipe, but the promised corrective action addressing the source of condensation does not address the in-use cheese rakes resting on an unclean wall. The handwashing sink was repaired on October 25, 2015 and the employees were retrained not to hang tools for cheese making on the handwashing sink, but due to this observation being repetitive we will need to verify the implementation of this corrective action. You also stated you retrained your employees to place the hoop pins in a bucket filled with sanitizer; however, due to lack of supporting documentation we are unable to determine the adequacy this corrective action.
In addition, in your response you indicate you are looking into purchasing an adenosine triphosphate (ATP) unit and you plan to purchase one by the end of the year. Purchasing an ATP unit does not adequately address the elevated APC counts and lack of cleaning and sanitizing. Your firms testing protocol for food contact surfaces states, that “in the event that there is a positive test we will clean and sanitize the tool/area, and immediately retest”. No cleaning and retest was performed after the positive result or was discussed in your response.
Sanitary Facilities and controls:
2. Plumbing at your firm constitutes a source of contamination to food, water supplies, equipment, and utensils, as required by 21 CFR 110.37(b)(3). Specifically, our investigator observed the following:
a. The (b)(4) machine in the make room is connected to the potable water supply and a chemical dispenser with no apparent backflow prevention installed on the water line.
b. The hose with spray nozzle attached to it located on the south wall of the make room near Tank #(b)(4) is not fitted with backflow prevention.
Your response states a plumbing and heating company was contacted to install backflow prevention on your system; however, no documentation was provided to indicate the corrective action was completed. We are unable to determine the adequacy without additional documentation. This was a repeat from the January 2015 inspection.
Plant and grounds:
3. Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food packaging materials, as required by 21 CFR 110.20(b)(6). Specifically, on October 13, 2015, steam and condensation was observed filling the entire room while the hoop cleaning machine was in operation. The air intake fan located near the center of the north wall of the make room is fitted with a furnace air filter. While steam was in the room, we observed the air blowing from this fan directly onto Vat (b)(4), which contained in-process Monterey Jack cheese curds and whey.
Your response states a plumbing and heating company was contacted to build a filter housing to make it air tight; however, no documentation was provided to indicate the corrective action was completed or that a temporary corrective action has been implemented to prevent in-process product from contamination. This response is inadequate.
4. You failed to construct the plant and facilities in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4). Specifically, on October 13, 2015, steam and condensation was observed filling the entire room while the hoop cleaning machine was in operation. Condensation was observed on the ceiling above open Vat (b)(4) containing in-process Stirred Curd Cheddar. The condensation was observed falling into an empty Vat (b)(4). The condensation was observed dripping onto the cheese cutting apparatus hanging on the north wall.
Your response states the problem can be fixed by repairing the exhaust fan. Your plan is to cut a hole in the top of the hoop washer, extending the exhaust pipe through the ceiling. You did not submit documentation of this promised correction or of the effectiveness of this correction.
5. You must take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food contact surfaces, and food packaging materials, shall conform to hygienic practices while on duty to the extent necessary to prevent the contamination of food, including washing hands thoroughly when hands may have become soiled or contaminated, to comply with 21CFR 110.10(b)(3).Specifically, on October 13, 2015, during the production of stirred Cured Cheddar and Monterey Jack cheeses, we observed an employee wiping sweat from their head and returned to work handling cheese hoops and cloths without washing hands. On October 14, 2015, during production of Monterey Jack cheese, we observed an employee rinsing their hands with chlorine water instead of washing hands between tasks, including in-process cheese with bare hands.
Your response explains that you have retrained your employees concerning the hand washing policy; however, this was a repeated observation from the December 2014 inspection and the training effectiveness will be verified during the next inspection.
Equipment and utensils:
6. Your firm failed to have smoothly bonded or well-maintained seams on food contact surfaces, to minimize accumulation of food particles and the opportunity for growth of microorganisms, as required by 21 CFR 110.40(b). Specifically, on October 13, 2015 and October 14, 2015, we observed several food contact surfaces with rough or cracked welds: cheese hoop funnel with crack and crevice in one interior corner; multiple cheese hoop covers with cracked corners; and a mixing blade in Vat (b)(4) with a damaged blade and metal gouge.
Your response states that you plan to repair and replace all cracked tools as needed. You also explain that you are working with a (b)(4) to purchase new lids as well as a fabricator to make repairs; however, no documentation was provided to indicate the items documented were repaired or replaced.
This letter is not intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act, and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. Your firm should take prompt action to correct the violations addressed in this letter, and additional measures to prevent contamination of your cheeses products You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Your firm’s response should be sent to: LCDR Kelli Wilkinson, Compliance Branch, Food and Drug Administration, Detroit District Office. If you have any questions about the contents of this letter, please contact: LCDR Kelli Wilkinson, Compliance Officer, at 313-393-8120.
Detroit District Office
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