Inspections, Compliance, Enforcement, and Criminal Investigations
Very Fresh Juice Company 8/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-277-3466
August 26, 2009
VIA Federal Express
WARNING LETTER CIN-09-38598-14
Noel G. Luhn, President
Very Fresh Juice Company
3975 Dayton Park Drive
Dayton, OH 45414-4422
Dear Mr. Luhn:
We inspected your juice processing facility, located at 3975 Dayton Park Dr., Dayton, OH 45414, on June 18 – July 7, 2009, and found that you have serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP system that complies with 21 CFR 120.6, 120.7, and 120.8, or otherwise to operate in accordance with the requirements of this part, shall render your juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Therefore, all of your 100 % juices are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
You can find the Act and the juice HACCP and food labeling regulations through links in FDA’s home page at www.fda.gov.
The observations of significant concern to us are as follows:
1. You must have a written HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 120.8(b)(3). However, your firm’s HACCP plans for “Orange Juice Concentrate and Concentrate Blends”, “100% Apple Juice Concentrate and Apple Juice Blend Concentrates”, “100% Pear Juice Concentrate and Pear Juice Blend Concentrates”, “100% Pineapple Juice Concentrate and Pineapple Juice Blend Concentrates”, “100% White Grape Juice Concentrate and White Grape Juice Blend Concentrates”, “100% Prune Juice Concentrate and Prune Juice Blend Concentrates”, “100% Cranberry Juice Concentrate and Cranberry Juice Blend Concentrates”, “100% White Cranberry Juice Concentrate and White Cranberry Juice Blend Concentrates”, “100% Concord Grape Juice Concentrate and Concord Grape Juice Blend Concentrates”, “100% Grapefruit Juice Concentrate and Grapefruit Juice Blend Concentrates”, “100% Lemon Juice Concentrate and Lemon Juice Blend Concentrates”, “100% Lime Juice Concentrate and Lime Juice Blend Concentrates”, “100% Aronia Juice Concentrate and Aronia Juice Blend Concentrates”, “100% Mango Juice Concentrate and Mango Juice Blend Concentrates”, “100% Orange Pulp Concentrate and Orange Pulp Blend Concentrates”, and “100% Lemon Pulp Concentrate and Lemon Pulp Blend Concentrates” list the critical limit in each of the plans as obtaining a letter of guaranty with each shipment of juices and pulps, at the receiving critical control point that is not adequate to control pathogens in the finished products. The control measures listed in your firm’s HACCP plans do not achieve the minimum five-log pathogen reduction in the pertinent microorganism in these products as required under 21 CFR 120.24.
2. You must have sanitation control records to document monitoring and corrections, to comply with 21 CFR 120.6(c). However, our inspection found that your firm has not maintained any sanitation records since April 3, 2009.
This letter may not be an all inclusive list of violations at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Failure to promptly correct violations may result in regulatory action being initiated by the Food and Drug Administration without further notice, such as seizure and/or injunction.
You should submit your written response to this office within fifteen (15) working days of receipt of this letter. Your response should include each step you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be sent to the Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 164.
Teresa C. Thompson
cc: Charles Kirchner, Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399