Inspections, Compliance, Enforcement, and Criminal Investigations

Sunnyside Orchard 2/19/19

 

  

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February 19, 2019
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to CMS 574552
 
 
Theodore Huisinga, President
Randall E. Huisinga, Vice President
Sunnyside Orchard
1118 Southwest Fifth Street
Willmar, Minnesota 56201-3423
 
Dear Messrs. Huisinga:

 
The U.S. Food and Drug Administration (FDA) inspected your apple cider processing facility located at 6051 75th Street NW, Pennock, Minnesota, between September 27 and October 12, 2018. We found that you have serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120 renders your juice products 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). Accordingly, your apple cider is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links on FDA's home page at www.fda.gov.
 
To date, the agency has not received a written response from your firm regarding the violations noted on the Form FDA-483, Inspectional Observations, which was issued to you at the conclusion of the inspection.

The significant violations include, but are not limited to, the following:
 
1.    Your firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of apple cider, as required by 21 CFR 120.10(a):
 
      The Corrective Action section of your HACCP plan states that your (b)(4) unit (identified as Critical Control Point # (b)(4)) “won’t operate if process critical limits are not provided.”  However, on September 27, 2018, while the (b)(4) unit was powered off, raw unprocessed cider was allowed to move forward through the (b)(4) and into the clear exit tube from the machine that leads into the Chiller Tank.  You indicated during the inspection that this type of forward flow of raw cider routinely happens at start-up of each batch, with the raw cider continuing through the process to packaging.
 
This observation indicates cider being processed in your (b)(4) may not be receiving an adequate UV treatment, and that the unit allows product to pass though it when not in operation.
 
2.    The corrective actions identified on Critical Control Point (CCP) #(b)(4), UV (b)(4) 5-log reduction, of your HACCP Plan are inappropriate to comply with 21 CFR 120.8(b)(5). Specifically, your corrective action procedures do not address the cause of the aforementioned deviation of the (b)(4), nor do they ensure that under-processed cider is prevented from being introduced into commerce.
 
3.    You did not implement the monitoring procedures listed in your HACCP plan as required in 21 CFR 120.8(a). Specifically, the following observations were made during our review of your HACCP plan:
 
      At (CCP)#(b)(4), Culling for the Hazard Patulin, you state the Production Manager will visually inspect and cull defective apples for core rot, with a (b)(4) sample collected for each production batch each day. This will be documented on the “Visual/Cut core rot sample record.” During the inspection we did not observe a (b)(4) sample being collected, nor did we observe anyone using any record to document culling.
 
      At CCP#(b)(4), Screen for the Hazard Metal Inclusion, you state that a visual inspection will be made of the screen daily at (b)(4) by the Production Manager and documented on the “Production Pre-op inspection records.” During this inspection we did not observe you conducting screen checks, nor did we observe anyone using any record to document screen checks. 
 
      At CCP #(b)(4), UV (b)(4) 5-log Reduction, you identified printouts from your (b)(4) unit as your monitoring record to ensure that the required 5-log reduction for pertinent microorganisms is being met.  However, during our review of your production records for 2017 and 2018, we note that the volume of product documented on the printouts differs from your actual amount processed. For example, on September 27, 2018, the printout indicates that (b)(4) gallons of cider was processed; however the actual amount that you documented on your Production Log was (b)(4) gallons.
 
4.    You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b).  However, your firm did not monitor the condition and cleanliness of food contact surfaces; protection of food, food packaging material, and food contact surfaces from adulteration; and exclusion of pests from the food plant as evidenced by:
 
      Your firm cleans all equipment with high pressure hoses, which includes a pressure washer, using only a detergent and potable water.  Sanitizer is not routinely used to clean any of the processing equipment.
 
      On October 3, 2018, after sanitation had occurred, a buildup of debris and/or product residue was observed on the storage and chiller tanks, accordion press, hammer mill, filler heads, filler head primer, and equipment valves.  The filler heads and filler head primer are finished product food-contact surfaces.
 
      On September 27, 2018, we observed evidence of rodents and pests in your facility, including at least 20 rodent excreta pellets in the motor compartment of the Chiller Tank and fruit flies, too numerous to count, in the processing room inside the balance tank, on the cooler tank, and inside the filler trough, while your firm was actively processing cider.
 
Furthermore, you must maintain sanitation control records that, at a minimum, document sanitation monitoring and corrections, as required by 21 CFR 120.6(c).
 
Conclusion
 
The above is not intended to be an all-inclusive list of violations. As a manufacturer of food intended for human consumption, you are responsible for ensuring your overall operations and the food you manufacture and distribute are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection 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 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 reinspection-related costs.
 
In addition to the violations listed above, we have the following comment:
 
(b)(3)(A)
 
You should respond in writing within 15 business days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these violations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrections (including how you intend to address systemic problems) your firm has taken. If your firm’s planned corrections will occur over time, please include a timetable for implementation of those activities. If corrections cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed.
 
Please send your written response to Dianna C. Sonnenburg, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Ave, Suite 600, Minneapolis, MN 55401. If you have questions regarding any issues in this letter, please contact Ms. Sonnenburg at (612) 758-7125.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations

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