Company: Brede, Inc.
Subject: CGMP/Adulterated/Misbranded
Issuer: Detroit District Office
Issued: Aug. 21, 2008 Closed:
Not applicable.
Source ucm1048169 Archive Code:

Brede, Inc. 21-Aug-08

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX 313-393-8139



August 21, 2008

Mr. Michael J. Brede, President
Brede, Inc.
19000 Glendale Street
Detroit, Michigan 48223-3424

On June 3-18, 2008, the Food and Drug Administration (FDA) conducted an inspection of your horseradish and horseradish-based manufacturing facility located at 19000 Glendale Street, Detroit, Michigan. We found that you have significant deviations from the current Good Manufacturing Practice (cGMP) regulations for food manufacturers (Title 21, Code of Federal Regulations (CFR), Part 110). These violations cause the foods manufactured at your facility to be 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 were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at .

Specifically, our inspection of your facility revealed the following sanitation deviations:

1. In order to comply with section 21 CFR § 110.40(a), all plant equipment shall be properly maintained. In addition, under §§ 110.40(c) and (d), equipment that does not contact food must be constructed so that it can be kept in a clean condition, and, further, conveying and manufacturing systems must be designed and constructed to be maintained in an appropriate sanitary condition. Specifically observed by our investigators on June 5, 2008, was an employee dispensing prepared horseradish with a white plastic pipe that had been retrieved from the floor, without being washed or sanitized.

2. On June 3, 2008, our investigators observed an employee smoking in a break room within one foot of containers to be used for packaging food. 21 CFR § 110.10(b)(8) prohibits using tobacco where food may be exposed. In addition, 21 CFR § 110.80(b)(7) requires that containers used to convey or hold food shall be handled and maintained during storage "in a manner that protects against contamination."

3. In order to comply with 21 CFR § 110.35(a), buildings, fixtures, and other physical facilities of your plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. Additionally, 21 CFR § 110.40(a) requires that all plant equipment and utensils be designed to be adequately cleanable, that they be properly maintained, and that all food-contact surfaces be maintained to prevent food from being contaminated by any source.
Specifically observed by our investigators prior to start up of production were the following:

• The interior surface of the tumble rinser with a build-up of horseradish root residue up to at least six (6) inches long.
• Horseradish roots residue buildup on the inclined conveyor belt used to move rinsed horseradish roots to the hammer mill.
• Debris on the opaque plastic drip tray-used to catch product between the 128 oz. plastic container filler and on the metal rack used to hold the plastic jugs.

4. In order to comply with 21 CFR § 110.40(a), all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. Under 21 CFR § 110.40(b), seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. Specifically observed by our investigators, prior to start up of production on June 3, 2008, were three (3) pieces of horseradish root lodged between the canvas piece of the conveyor and the stainless steel housing. These roots were observed to have what appeared to be a grayish-white mold growth. The same three (3) pieces were again observed on June 5, 2008.

5. In order to comply with 21 CFR § 110.35(c), effective measures shall be taken to exclude pests from entering the processing area and protect against contamination of food on the premises from pests.

On June 5, 2008, immediately prior to the start of production, our investigators observed one (1) winged insect resting on the horizontal conveyor belt following the tumble rinser. Additionally, four (4) flying insects were observed on the food-contact surface of the inclined conveyor leading to the hammer mill. Rinsed horseradish roots were transported on these conveyor lines without any further cleaning or sanitizing. Also, on June 3, 2008, our investigators observed not less than 30 black-colored insects flying under the paddle conveyor, where there was a sheeting hanging near the hammer mill. The bay door to your warehouse area was observed to be left open on this same date.

6. In order to comply with 21 CFR § 110.37(b)(3), your plant shall be equipped with adequate sanitary facilities and accommodations. Plumbing shall be of adequate size and design and adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition.

On June 5, 2008, our investigators observed the red hose used for rinsing horseradish roots (in the tumble rinser) resting inside the floor drain, submerged in approximately one foot of water from the previous day. This line is not equipped with a backflow prevention device. The hose is attached to the manifold used to supply the tumble rinser with rinse water and was used for production of prepared horseradish.

7. In order. to comply with 21 CFR § 110.40(a), all food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.

Our investigators observed that the interior surface of the cylindrical tumble rinser, used to rinse each pallet of horseradish roots, had a heavy rust-colored discoloration and what appeared to be corrosion. The mesh-like interior metal surface also had uneven and bent edges indicative of broken off and worn down metal pieces. This tumbler was observed to be used to rinse horseradish roots for preparing finished horseradish.

The above violations are not meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food to legal action. It is your responsibility to assure that your processing plant operates in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.

You should 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 violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to the Food and Drug Administration, Attention: Judith A. Jankowski, Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact Judith A. Jankowski at 313-393-8125.



Joann M. Givens
District Director
Detroit District Office