River Valley Ranch Ltd 8/18/11
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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
August 18, 2011
RETURN RECEIPT REQUESTED Refer to MIN 11 – 45
Eric B. Rose
River Valley Ranch Ltd.
39900 60th Street
Burlington, Wisconsin 53105
Dear Mr. Rose:
An inspection of your facility located at 39900 60th Street, Burlington, Wisconsin, was conducted by investigators from the Food and Drug Administration (FDA) on April 18-20, 27 and May 2, 2011. This inspection verified that your firm manufactures and distributes food products, including various acidified food products.
As a manufacturer of acidified foods, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). The Emergency Permit control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 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 108.25, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. In addition, based upon certain criteria in Part 114, acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act, 21 U.S.C. § 342(a)(3), in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4), 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. Your firm’s failure to fulfill the requirements of 21 CFR 108.25 and the mandatory requirements of 21 CFR 114 renders your River Valley Ranch brand Key Lime Mango Salsa, Spinach Artichoke Dip, Portabella Salsa with Key Lime Juice, Shroomschetta Mushroom Bruschetta, Portabella Pasta and Dipping Sauce, Spicy Shrooms, Dill and Garlic Pickled Mushrooms, and Wild Mushroom Burgundy Pasta and Dipping Sauce products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and the Acidified Food regulations through links on FDA’s home page at http://www.fda.gov.
The significant violations we found at your acidified food processing facility are as follows:
- Your firm failed to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size in violation of 21 CFR 108.25(c)(2). Specifically, your processing authority identified eight products (key lime mango salsa, spinach artichoke dip mix, portabella salsa with key lime juice, shroomschetta, portabella pasta and dipping sauce, pickled spicy mushrooms, pickled garlic mushrooms with dill, and wild mushroom burgundy pasta and dipping sauce) as acidified foods but you have failed to submit the scheduled processes for them.
- Your firm fails to examine containers often enough to ensure that containers suitably protect the food from leakage and contamination in violation of 21 CFR 114.80(a)(4). Specifically, you check product container integrity (b)(4) but if a container is found to lack closure integrity, only the case of product which contained that container is inspected. The remainder of the batch is not checked.
- Your firm fails to maintain records which identify the initial distribution of finished product in violation of 21 CFR 114.100(d).
- Your firm fails to exercise sufficient control including recording of results so that the finished equilibrium pH values are not higher than 4.6 in violation of 21 CFR 114.80(a)(2). Specifically, your records indicate that a pH is taken (b)(4) batch of product but you usually take the pH from (b)(4) batch manufactured (b)(4) batches are made in one day.
We are in receipt of your letter on June 2, 2011, responding to the Form FDA-483, Inspectional Observations, issued on May 2, 2011, as a result of our inspection of your firm. It has been made a part of the Minneapolis District’s permanent file for your firm. The effectiveness of the corrections you have made or will be implementing will be evaluated during the next inspection.
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
Failure to make prompt corrections may result in enforcement action, including seizure, injunction, and emergency permit actions being initiated by the Food and Drug Administration (FDA). This letter does not represent a comprehensive review of all of the products distributed by your firm. As president, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.
Gerald J. Berg