| Public Health Service Food and Drug Administration |
Detroit District |
Department of Health and Human ServicesWARNING LETTER
2011-DET-05
February 23, 2011
VIA UPS
Thomas W. Kercher, President
Sunrise Orchards, Inc.
19498 County Road 38
Goshen, IN 46526-9135
Dear Mr. Kercher:
The U.S. Food & Drug Administration (FDA) inspected your juice processing facility, located at 19498 County Road 38, Goshen, IN 46526 on October 1, 4-5, 13, and 18-19, 2010. 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) and the Current Good Manufacturing Practices (CGMP) regulation for food (21 CFR Part 110). 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, or otherwise to 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 “100% 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, FDA’s juice HACCP regulations and guidance, and labeling regulations on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. You must maintain records documenting your HACCP system, as required by 21 CFR 120.12(a). However, your firm did not maintain monitoring records at the Culling Critical Control Point (CCP). According to your “Pasteurized Refrigerated Apple Juice” HACCP plan, your culling CCP lists the following critical limit: “undamaged apples, <50 ppb patulin, >5 apples per 100 showing decay or moldy.” However, your firm does not record your culling activities which ensure that you only process undamaged apples. Your HACCP plan states that you will continuously monitor to ensure that “moldy, rotten, bruised or otherwise damaged fruit” will not be processed into juice; however, FDA’s inspection revealed that your firm used a bin of apples containing numerous damaged apples for production of your 100% Apple Cider.
In addition, the FDA investigator noted seven days in 2009, and three in 2010, that you pressed apples for your 100% Apple Cider; but failed to maintain records demonstrating that you checked to ensure the metal screen was intact; per your “Pasteurized Refrigerated Apple Juice” HACCP plan’s “metal inclusion” CCP.
2. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with the conditions and practices specified in the CGMP regulation in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, our inspection showed that your firm did not monitor the following with sufficient frequency:
Condition and cleanliness of food contact surfaces, as evidenced by: Post-pasteurization piping is connected to the surge tank with duct tape. According to an employee, this piping is only cleaned using a water flush. In addition, the juice batch tank lid holes are closed with duct tape.
Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants, as evidenced by: Pasteurized apple juice was observed leaking from piping leading from the surge tank to the rotary filler and dripping on the outer surface of the rotary filler directly onto the bottle filling line. An opened, half-filled bottle of pasteurized juice was kept in an area adjacent to the jug wash spray, subjecting the bottle to spray mist of water that has hit the conveyor belt before the bottle was filled, capped, and boxed. There was a hole in the roof of the storage area where two torn bags of rice hulls were observed, exposing the rice hulls to the environment.
Proper labeling, storage and use of toxic compounds, as evidenced by: Unlabeled hand spray pumps of (b)(4) chemical sanitizer were stored adjacent to the apple wash tank.
Exclusion of pests, as evidenced by: Numerous fruit flies were observed on and around the surge tank, on piping leading to the makeup tank, on piping leading from the pasteurizer to the bulk storage tank, and piping from the surge tank to the rotary filler. At least two gaps were observed; one under the garage door and the other in the south wall. These gaps could allow entry of pests into the facility. In addition, a hole was observed in the roof of the storage area.
In addition, it is important that you not only monitor sanitation, but maintain monitoring records documenting your implementation of your Sanitation Standard Operating Procedures (SSOPs) to comply with 21 CFR 120.6(c).
3. You must hold foods that can support the rapid growth of undesirable microorganisms, in a manner that prevents the food from becoming adulterated, as required by 21 CFR 110.80(b)(3).
However, you failed to maintain your 100% Apple Cider at refrigerated temperatures to prevent the rapid growth of undesirable bacteria. Our investigation revealed that your 100% Apple Cider was stored in an unrefrigerated storage tank for up to 7 days prior to bottling. Undesirable microorganisms, such as bacteria and molds, could possibly grow in your pasteurized apple cider under unrefrigerated conditions.
We acknowledge your written response to the FDA 483, List of Inspectional Observations, received on January 19, 2011; however, your response to the violations above was deemed inadequate because it lacked documentation of your corrections, such as monitoring records covering your implementation of your apple juice HACCP plan, processing sanitation, and the implementation of your SSOPs.
This letter does not list all of the violations observed at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, and FDA’s implementing regulations, including the juice HACCP regulation (21 CFR Part 120) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).
You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
For your information, a FDA Guidance for Industry, titled “Juice HACCP Hazards and Controls,” that may be helpful to your firm is available on FDA's website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps that you are taking to correct these violations. You should include in your response documentation such as HACCP 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 violations.
Your reply should be sent to the Food and Drug Administration, Attention: CDR Kimberly Y. Martin, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Compliance Officer Martin (317) 226-6500 extension 116.
Sincerely,
/s/
Joann M. Givens
Detroit District Director
Detroit District Office
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