Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
January 5, 2012
Mr. Travis J. Keyes
Triple D Orchards, Inc.
8310 W. Stormer Road
Empire, MI 49630
Dear Mr. Keyes:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility, located at 8310 W. Stormer Road, Empire, MI from August 31, 2011 through September 9, 2011 and on September 21, 2011. The inspection revealed that you are manufacturing juices and you have serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 & 110).
In accordance with 21 CFR 120.9, failure of a processor of juice or juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice or 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 tart cherry juice product 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 in FDA's home page at www.fda.gov.
The significant juice HACCP violations documented during this inspection include the following:
1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur as required by 21 CFR 120.8(a). However, you do not have a HACCP plan for the tart cherry concentrate manufactured by your firm. Furthermore, your firm lacks a written hazard analysis to determine whether there are
2. food hazards that are reasonably likely to occur, and to identify control measures that can be implemented to control identified hazards as required by 21 CFR 120.7(a). On August 28, 2009 your firm submitted a 483 response letter informing the FDA that you were developing a HACCP plan and hazard analysis. As of the current inspection the plan and analysis were not completed and are not being implemented.
3. You must perform a 5-log reduction, in the pertinent microorganism(s), to comply with 21 CFR 120.24(a). This 5-log reduction and final product packaging must be accomplished in your facility through treatments applied directly to the juice to comply with 21 CFR 120.24(b) and (c). However, your firm fails to perform a 5-log reduction of the pertinent microorganism(s) in your cherry juice concentrate.
The significant Current Good Manufacturing Practice violations documented during this inspection include the following:
1. You failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7).
Specifically, during the production of maraschino cherries the investigator observed conditions that will enable pests to enter the facility.
- On August 31, 2011 the glass was removed from two windows on the east side of production room (b)(4). The glass was replaced by strips of clear plastic with missing sections creating gaps to allow for pests to enter the facility.
- On August 31, 2011 the east fork truck entry door of production room (b)(4) was open. The investigator observed flying insects passing in and out of the gaps in the plastic strips covering the entry.
- On August 31, 2011 and on September 2, 2011 the southwest fork truck entry door of production room (b)(4) was open. The investigator observed numerous flying insects entering the in-operation brine cherry staging area and the adjacent maraschino cherry operation.
- On September 2, 2011 during the production of tart cherry juice concentrate the west fork truck entry door was left open.
The above is not intended to be an all-inclusive list of violations. You are responsible for ensuring that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations. Your response should include each step that has been taken or will be taken in the future to correct the violations and prevent their recurrence. If you cannot complete all corrections before your response, please state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be directed to Cicely N. Vaughn, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Vaughn at 313-393-8297.
Glenn T. Bass
Detroit District Office