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  5. Rees Fruit Farm Inc - 511471 - 12/05/2016
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WARNING LETTER

Rees Fruit Farm Inc MARCS-CMS 511471 — Dec 05, 2016

Rees Fruit Farm Inc - 511471 - 12/05/2016


Recipient:
Rees Fruit Farm Inc


United States

Issuing Office:
Kansas City District Office

United States


 

  

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Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

 

December 05, 2016
 
SENT VIA UPS
 
WARNING LETTER
Ref. CMS Case# 511471
 
Mr. Rex E. Rees, Owner
Rees Fruit Farm, Inc.
2476 Hwy K4
Topeka, KS 66617
 
 
Dear Mr. Rex E. Rees,
 
The U.S. Food and Drug Administration conducted an inspection at your manufacturing facility located at 2476 Hwy K4, Topeka, KS on October 11, 13, and 14, 2016. The inspection found significant violation of the FDA’s Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CF Part 110). These violations cause the foods manufactured at your facilities 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 rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page  www.fda.gov.
 
The inspection of your facility on October 11, 13, and 14, 2016 revealed the following CGMP violations:
 
1.    Your firm failed to clean and sanitize food-contact surfaces in wet-processing before use, to preclude contamination with microorganisms, in accordance with 21 CFR 110.35(d)(2).
 
Specifically, your firm failed to sanitize food contact surfaces prior to the production of your apple cider on 10/10/16 and prior to the bottling of that cider on 10/11/16. The last time you sanitized the food contact surfaces was on 9/19/16.  Food contact surfaces include; hoses used to transfer finished apple cider to holding tanks prior to bottling, a plastic watering can used to hold finished apple cider to assist in filling product bottles, the final holding tank prior to bottling, and the cider filling trough used for bottling.  Failing to sanitize before each manufacturing batch may not protect against the introduction of microorganisms into food.
 
2.    Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as necessary, in accordance with 21 CFR 110.80(b)(1).
 
Specifically, the following equipment was observed to not be cleaned properly or kept in a manner to prevent contamination:
  • Hoses used to transfer apple pulp from the pulp holding tank to the apple press, repaired with duct tape, contained black accumulations on the inside of the tube.
  • The collecting pan on the apple press after cleaning had apple pulp on it.
  • Plastic splash guards under the collecting pan (used to keep freshly pressed cider from splashing out as cider drains from the collecting pan into a holding pan prior to being pumped into the holding tank) on the apple press were heavily soiled and apparent dead flies were stuck to them.
  • After bottling operations, a semitransparent hose, which had been cleaned, used to transport finished apple cider from the holding tank to the bottle filler, was observed to have apparent debris, black in color, on the outside and inside of the hose.
  • After bottling of finished apple cider, an employee was observed to be spraying down walls and equipment with a garden style hose. This water was observed to be splashing onto the open bottle filling trough.
3.    Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, in accordance with 21 CFR 110.35(c).
 
Specifically,
  • Flies too numerous to count were observed landing on production equipment during the bottling of finished apple cider. The manufacturing room does not have a door on it leaving it open to the rest of the facility.
  • The warehouse doors, leading to the outside, remained open during all three days of the inspection. Several cats were observed walking throughout the warehouse during each day of the inspection.  Pet bowls and food was observed around the inside and outside of the warehouse doors. 
To date, we have not received a written response to the Form FDA 483, List of Inspectional Observations that was issued.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
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. 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.
 
Your written response should be sent to Andrew A. Hoopes, Compliance Officer, at 210 Walnut St., Suite 369, Des Moines, IA 50309. If you have any questions about this letter, please contact Mr. Hoopes at 515-244-0480 ext 1002 or email him at andrew.hoopes@fda.hhs.gov.
 
 
Sincerely,
/S/
Cheryl A. Bigham
District Director
Kansas City District