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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Two Brothers Organics, Inc. 25-Aug-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6" Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

August 25, 2004



Mr. Jeffrey A. Schwartz, President
Two Brothers Organics., Inc.
386 High Street
P.O. Box 2012
Hotchkiss, Colorado 81419

Re: Den#-04-13

Dear Mr. Schwartz:

On April 7, 2004, an investigator from the Denver District Office collected a surveillance sample of "BIG B'S FABULOUS 100% ORGANIC PASTEURIZED... APPLE JUICE... [100% Juice]... 64 fl oz", lot 113004. As we advised you in correspondence on April 30, 2004, analysis of this product showed it contained 415 parts per billion (ppb) patulin, with a check analysis of 227 ppb patulin. Patulin is a toxic substance produced by molds that may grow on apples. Subsequently, we analyzed nine additional samples and found five of these samples with the following lot numbers to have analytical findings above 50 ppb. All products were from unlabeled containers collected from your firm:


Container size


Original analysis

Check analysis

Ginger Apple Juice

32 oz


71.9 ppb

66.1 ppb

Cherry Apple Juice

32 oz


159.8 ppb

182.0 ppb

Spiced Apple Cider

128 oz


161.3 ppb and

173.3 ppb

154.7 ppb

Apple Apricot Juice

64 oz


194.6 ppb

181.0 ppb

Apple Juice

64 oz


445.4 ppb

492.0 ppb

These articles of food, various types of apple juices, are adulterated when introduced into and while in interstate commerce and are adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342(a)(1), Section 402(a)(1) of the Federal Food Drug, and Cosmetic Act (the Act). They are adulterated in that they bear or contain an added poisonous or deleterious substance, patulin, which may render the articles of food injurious to health.

In addition, we inspected your firm, located at 386 High Street, Hotchkiss, Colorado, on May 3-6, 2004 and found that you have serious deviations from the Juice Hazard Analysis Critical Control Point (HACCP) Regulations found in Title 21, Code of Federal Regulations, Part 120(21 CFR 120). These deviations cause your cold pressed [redacted] apple juice products and your pasteurized [redacted] apple juice products to be adulterated under section 402(a)(4) of the Act. You can find the Act and the Juice HACCP Regulations through links in FDA's homepage at www.fda.gov.

The deviations we found during our inspection are as follows:

1. You must have 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 plan for cold pressed [redacted] apple juice products to control the food safety hazards of patulin and pathogens. Additionally, your firm does not have a HACCP plan for pasteurized [redacted] apple juice products to control the food safety hazard of patulin.

Furthermore, you must develop, or have developed for you, a written hazard analysis to determine whether there are any food safety hazards that are reasonably likely to occur for each type of juice that you process and to identify control measures that you can take to control those hazards, to comply with 21 CFR 120.7(a). Your firm does not have a written hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards for your apple juice products.

2. You must have sanitation control records that document monitoring and corrections to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records for the safety of water that comes into contact with food or food contact surfaces; the cleanliness of food contact surfaces; the prevention of cross contamination; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants; the proper labeling, storage, and use of toxic compounds; the control of employee health conditions; and the exclusion of pests from the food plant.

We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your products and/or enjoin your firm from operating. We have received a letter from you on June 21, 2004 in response to the FD 483 issued to you at the close of the inspection, agreeing with the deviations listed by the investigator, and promising correction by the initiation of the next processing season. Your response did not provide any specifics as to how correction was to take place, only that it would take place, and that you would be providing the District Office with future updates.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response, documentation such as your HACCP Plan verification, validation of equipment, sanitation control records, or any other useful information that will 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.

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 and the Current 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.

Please send your reply to the Food and Drug Administration, Attention: Ms. Shelly L. Maifarth, Compliance Officer, P.O. Box 25087, Denver, Colorado 80225-0087. If you have questions regarding any issue in this letter, please contact Ms. Maifarth at (303) 236-3046.



B. Belinda Collins
District Director