Inspections, Compliance, Enforcement, and Criminal Investigations
Aranda's Pickled Mushrooms, LLC 11/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
260 Marquette Avenue, Suite 600
Minneapolis, MN 65401
Telephone: (612) 334-4100
FAX: (612) 334-4142
November 16, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 08
Randall R. Schopen
Aranda's Pickled Mushrooms, LLC
N4733 S. Farmington Road
Helenville, Wisconsin 53137-9751
Dear Mr. Schopen:
An inspection of your facility located at N4733 S. Farmington Road, Helenville, Wisconsin, was conducted by investigators from the Food and Drug Administration (FDA) on June 21, 23, and 28-29, 2011. This inspection verified that your firm manufactures and distributes food products, specifically 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 Aranda's brand Whole Pickled Mushrooms adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
Additionally, your Aranda's brand Whole Pickled Mushrooms are misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343, in that your product label contains false or misleading statements. Your Aranda's brand Whole Pickled Mushrooms are further misbranded within the meaning of section 403 of the Act in that your product label is not in accordance with the Food Labeling Regulations at 21 CFR 101. You can find the Act, the Acidified Food, and the Food Labeling 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:
1. Your firm fails to manufacture acidified food in conformity with at least the scheduled process filed with the FDA in violation of 21 CFR 108.25(c)(3)(i). Specifically, the filed scheduled process for Pickled Mushrooms calls for the product to be cooked and held at (b)(4)°F for (b)(4) However, our investigators observed your employees failing to document the processed time of your pickled mushrooms.
2. Your firm fails to exercise sufficient control to ensure that the finished equilibrium pH values are not higher than 4.6 in that you do not conduct equilibrium pH testing on all finished batches of product in violation of 21 CFR 114.80(a)(2).
3. Your firm fails to maintain processing and production records showing adherence to the scheduled processes in that you do not document the time and temperature of the initial temperature and the hold time at this temperature nor do you document that the cook time has met the scheduled process in violation of 21 CFR 114.100(b).
4. Your firm fails to employ appropriate quality control procedures to ensure that finished foods do not present a health hazard. You fail to maintain calibration records for thermometers used for measuring in-process and finished product temperatures, you failed to discard a jar of product which contained mushrooms above the acidulant solution in the jar, (b)(4) when you do equilibrium pH testing, and you calibrate your pH meter using (b)(4) to ensure accuracy across its use in violation of 21 CFR 114.80(a).
5. Your firm fails to maintain records which identify the initial distribution of finished product in violation of 21 CFR 114.100(d). Specifically, several instances where the initial distribution of finished products was not documented were noted during the inspection.
We are in receipt of your letter dated July 12, 2011, responding to the Form FDA-483, Inspectional Observations, issued on June 29, 2011, as a result of our inspection of your firm. Your letter has been made a part of the Minneapolis District's permanent file for your firm. As no supporting evidence was submitted with your response, the effectiveness of the corrections you have made or will be implementing will be evaluated during the next inspection.
6. Your Whole Pickled Mushrooms product is misbranded within the meaning of section 403(i)(2), 21 U.S.C. § 343(i)(2), of the Act in that your label fails to declare completely all of the ingredients used by your firm in the production of these pickled mushrooms in accordance with 21 CFR 101.4. Specifically, your Whole Pickled Mushrooms recipe sheet declares "orange juice, citric acid, and minced garlic"; however, these ingredients are not declared on your label in accordance with 21 CFR 101.4(a)(1). Furthermore, the orange juice is comprised of several sub-ingredients which are not listed on the finished product label, 21 CFR 101.4(b)(2). During the inspection, our investigator also observed lemon juice being incorporated during the manufacturing process. Thus, if lemon juice is one of the ingredients used by your firm in the production of pickled mushrooms; it would also be required to be declared on the product label.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
7. Your Whole Pickled Mushrooms product is misbranded within the meaning of section 403(a)(1), 21 U.S.C. § 343(a)(1), of the Act in that your label contains false or misleading statements. Specifically, your Whole Pickled Mushrooms product label makes the claim "No Preservatives"; however, the reconstituted lemon juice that our investigators observed being incorporated into your Whole Pickled Mushrooms product contains the preservatives Sodium Bisulfite and Sodium Benzoate.
8. Your Whole Pickled Mushrooms product is misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1), because the product fails to declare the place of business as required by 21 CFR 101.5. The labels in use at the time of the inspection list the mailing location of the business as P.O. Box 9 and the firm's street address is not listed in a current city or telephone directory. Accordingly, the label shall include the street address as required by 21 CFR 101.5(d). We also note the name of your firm is not declared in conjunction with the address.
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. 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.
We also have the following comments:
• Your product label includes "ascorbic acid" in the ingredient statement. However, the formulation reveals that it is not used in its manufacture. If at some point you decide to incorporate ascorbic acid in the manufacture of your Pickled Mushrooms, we note that ascorbic acid is classified as a chemical preservative within section 21 CFR 182.3013.
• The net quantity of contents for your Whole Pickled Mushrooms (16 oz and 64 oz) is not declared in accordance with 21 CFR 101.105(j)(1).
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
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.
Elizabeth A. Waltrip