Inspections, Compliance, Enforcement, and Criminal Investigations

H & W Farms LLC 3/22/17

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139
 

 

WARNING LETTER
2017-DET-03
 
 
March 22, 2017
 
VIA UPS
 
Timothy E. Heffron
President
H & W Farms, LLC
13375 Belding Road, NE
Belding,  Michigan 48809-9383
 
Dear Mr. Heffron:
 
The U.S. Food and Drug Administration (FDA) inspected your firm located at 13375 Belding Road NE, Belding, Michigan, on December 9, 2016. The inspection revealed that the juice products you manufacture are 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 been rendered injurious to health. During our inspection of your juice processing facility we found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 120.
 
You may find the Act and its implementing regulations through links on FDA's home page at http://www.fda.gov. For information to control food safety hazards associated with juice products, you may refer to The Juice HACCP Controls Guidance, First Edition: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Juice/ucm072557.htm.
 
Juice HACCP
 
During our inspection ending on December 9, 2016 we found 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 of juice products to have and implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. Therefore, your cherry juice concentrate is adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
 
1.    Your firm shall develop or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each juice you process, to comply with 21 CFCR 120.7(a).  The written hazard analysis shall consist of identification of food hazards to comply with 21 CFR 120.7(a)(1). A “food hazard” is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.”
 
2.    Your firm must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). Your firm does not have a HACCP plan for cherry juice concentrate.
 
3.    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).  Your firm does not currently monitor the sanitation of the juice bottling equipment on the line, employee health conditions, or pest activity in the production area.
 
We may take further action if you do not promptly correct these violations. Actions may include the initiation of a seizure against your products and/or an action to enjoin your firm from operating.
 
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. You should include in your response documentation such as copies of your Juice HACCP Hazard Analysis, juice HACCP plan, and sanitation monitoring records. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. 
 
Additionally, we offer the following comment:
 
Your firm fails to maintain equipment, containers and utensils used to convey food in a manner that protects against contamination. On December 9, 2016, the bin filler used to cushion juice apples at the west end of the apple conveyor was observed to have black product residues on the catch flaps. The flaps were also observed to be torn and unable to be cleaned. The flaps, as well as all equipment used to convey or contact apples, should be maintained clean and in good working order.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
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 re-inspection related costs.
 
Your response should be directed to Compliance Officer Boun M. Xiong at the address indicated on the letterhead. If you have questions regarding any issues in this letter, please contact Mr. Xiong at (414) 326-3976 or boun.xiong@fda.hhs.gov.
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office

Page Last Updated: 04/03/2017
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