Inspections, Compliance, Enforcement, and Criminal Investigations
Rowley's South Ridge Farms, Inc. 1/5/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
PO Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
January 5, 2011
Mr. Phillip Rowley, President/Co-owner
Mr. Tod M. Rowley, Co-owner
Rowley's South Ridge Farms, Inc.
300 West 900 South
Santaquin, UT 84655
Ref. # DEN-11-07
Dear Messrs. Rowley:
The Food and Drug Administration inspected your juice processing facility, 300 West 900 South, Santaquin, Utah, on September 28 - 30, 2010, 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 Parts 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 21 CFR §§ 120.6, 120.7 and 120.8 or otherwise operate in accordance with the requirements of Part 120, renders the 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 refrigerated juice products from fresh pressed apples and from concentrated cherry juice are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they 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.
Your significant violations were as follows:
1. You 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). However, your firm does not have a HACCP plans for the following products:
• You have not established a HACCP plan for the processing of your refrigerated South Ridge Farms Red Tart Cherry Juice Concentrate to control the food safety hazard of pathogen growth. In addition, you must conduct a written hazard analysis for your cherry juice concentrate product;
• You have not established a HACCP plan for the processing of your Red Barn Cider Mill Fresh Pressed Pasteurized Apple Juice to control the food safety hazards of patulin and pathogen growth. During the September inspection, you presented FDA investigators with a document entitled "HACCP plan for Apple Based Production." However, your "HACCP document" only consists of a cover page and a hazard analysis. Your hazard analysis identifies the pasteurization step as a significant hazard; however, you have not created a HACCP plan that contains critical control points, critical limits, monitoring procedures and the other requirements under 21 CFR 120.8(a).
2. You must maintain sanitation standard operation procedure records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation operating procedure records for the following areas of sanitation:
• Safety of the water and ice that comes in contact with food or food contact surfaces;
• Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
• Prevention of cross contamination from insanitary objects and raw product to food, and food contact surfaces;
• Maintenance of hand washing, hand sanitizing, and toilet facilities;
• Protection of food and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical, and biological contaminants;
• Proper labeling, storage, and use of toxic compounds;
• Control of employee health conditions that could result in the microbiological contamination of food and food contact surfaces; and
• Exclusion of pests from the food plant.
3. You must apply a 5-log reduction measure and perform final product packaging in a single production facility to conform with 21 CFR 120.24(c). However, you are not performing a 5-log pathogen reduction measure for your refrigerated South Ridge Farms Red Tart Cherry Juice Concentrate in the same facility in which you perform final product packaging to control the occurrence of the most resistant microorganism of public health concern that is likely in these products.
You should take prompt action to correct the violations described in this letter and establish procedures to ensure that these violations do not recur. We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further informal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the juice HACCP regulation and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
We acknowledge receipt of your letter dated October 15, 2010, responding to our Inspectional Observations, form FDA 483 dated September 30, 2010. Your response is inadequate in that you did not provide documentation of your corrective actions.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as copies of your juice HACCP Hazard Analysis and HACCP Plans; Standard Sanitation Operating Procedures; sanitation monitoring records; or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your written response should be sent to: U.S. Food and Drug Administration, P.O. Box 25087, (6th Ave. and Kipling Pkwy, DFC, Bldg 20), Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions about this letter, please contact Mr. Sherer at (303)236-3051, or by email at firstname.lastname@example.org
Karen S. Kreuzer
Acting Denver District Director