Hyline Orchards 9/6/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
September 6, 2013
via UPS Overnight Delivery
Refer to MIN 13 - 23
Loretta M. Robertoy
8240 Highway 42
Fish Creek, Wisconsin 54212
Dear Mrs. Robertoy:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified food facility located at 8240 Highway 42, Fish Creek, Wisconsin, on March 26, April 8 and April 30, 2013. The inspection revealed serious violations of the regulations for acidified foods, Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control, and Part 114, Acidified Foods (21 CFR 108 and 114). Accordingly, we have determined that your acidified food products 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 become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through links on FDA’s home page at http://www.fda.gov.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR 108, Emergency Permit Control, and in 21 CFR 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act, 21 U.S.C. § 344. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
During our inspection we observed the following significant violations:
- As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of any new product, provide the Food and Drug Administration information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size to comply with 21 CFR 108.25(c)(2). Specifically, your firm has not filed a scheduled process with FDA for all of the following acidified foods and each size container that your firm manufactures including End of Garden Salsa, Vegetarian Soup, pickle relishes, Dill Pickled Eggs, and Jalapeno Peppers Pickles.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic) either electronically or by paper submission. Publications addressing both methods of filing can be found at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm.
For additional information on the types of products FDA considers to be acidified foods (including thickened water beverages), please refer to the 2010 Draft Acidified Food Guidance Document at the following link:
- Your firm failed to ensure acidified foods are manufactured in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically:
- German Style Red Cabbage in 16 oz. glass jars produced on 8/30/12 (lot code 20201122) and on 3/1/2013 (lot code 20201181) was processed for (b)(4) minutes, and not processed for the (b)(4) minutes as stated in your scheduled process.
Further, this deviation from your scheduled processes was not recorded and set aside for evaluation by a competent processing authority in accordance with 21 CFR 114.89.
- Your firm failed to maintain processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production, to comply with 21 CFR 114.100(b). Specifically:
- Hot Dilly Mix produced on 12/9/12 (lot code 20201145) was not processed for (b)(4) minutes at (b)(4)°F. (b)(4). You did not measure the temperature during this time or maintain a boil.
- Dilly Bean Pickles in 32 oz. jars produced on 7/24/12 (lot code 20201111) and 8/2/12 (lot code 20201114) were not processed for (b)(4) minutes at (b)(4)°F. (b)(4). You did not measure the temperature during this time.
- Bread and Butter Pickles in 8 oz. jars were not processed for (b)(4) minutes at (b)(4)°F. Your procedure is (b)(4). You do not measure the temperature during processing.
- Dilly Asparagus in 20 oz. jars were not processed for (b)(4) minutes at (b)(4)°F. Your procedure is (b)(4). You do not measure the temperature during this time or maintain a boil.
- Your firm failed to maintain processing and production records including pH measurements and other critical factors for your Dilly Asparagus (shipped on 1/17/12), Pumpkin Butter (lot code 20201089), Hot Cherry Salsa (lot code 20201093), Hawaiian Salsa (lot code 20201100), and Jalapeno Pickles (lot code 20201118).
Further, these deviations from your scheduled processes were not recorded and set aside for evaluation by a competent processing authority in accordance with 21 CFR 114.89.
- Your firm failed to assure sufficient control, including frequent testing and recording of results so that the finished equilibrium pH values are not higher than 4.6 as required by 21 CFR 114.80(a)(2). However, a homogeneous mixture was not prepared to determine the final equilibrium pH of your acidified products as recommended by 21 CFR 114.90.
In addition, your Hot Jalapeno Cheese Sauce is labeled as “Keep Refrigerated After Opening” and may be a low acid canned food (LACF). As a LACF product, the cheese sauce would be subject to 21 CFR 108 and 113 requirements for LACF food products. The product is stored refrigerated. However, it was stated that the cheese sauce could be refrigerated or was shelf stable. To be exempted from the LACF regulations, the cheese sauce should be labeled as “Keep Refrigerated” and the product must be held and distributed under refrigerated conditions.
This letter is not intended to be an all-inclusive list of deficiencies in your plant and on your product labels. It is your responsibility to ensure that all of your products comply with the Act, the acidified food regulations (21 CFR 108 and 114), the Current Good Manufacturing Practice regulation (21 CFR 110), and other applicable regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
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 re-inspection related costs. 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.
Your response should be sent to the U.S. Food and Drug Administration, Attention: Demetria L. Lueneburg, Compliance Officer, at the address listed on this letterhead. If you have any questions with regard to this letter, you may contact Ms. Lueneburg at (612) 758-7210.
Michael Dutcher, DVM