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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Brede Inc. Warning Letter Response



e-mail: info@bredefoods.com


(313) 273-1079
FAX(313) 273-4110

Orig: DD/EF

August 26, 2008

Joann M. Givens
District Director, Detroit Office
Food & Drug Administration
300 River Place Suite 5900
Detroit; Ml 48223

Dear Ms. Givens,

I received a warning letter today (2008-DT-11) from you regarding a recent inspection Performed at my plant in Detroit. I must respond.

Enclosed is a copy of the letter I sent to your Department on July 14th of this year. It was sent regular mail, to the above address. No name was put on the envelope, as the inspection report simply had the FDA address.

Not only had the letter been sent on time, but the detailed list of deficiencies have been corrected, as noted on my letter.

I telephoned Judy Jankowski on July 17, July 25, and July 29 with no response. I did finally get a message from Ms. Jankowski on July 30 letting me know she would be gone until August 18th, and would call upon her return. That has not happened.

There are two issues I need to discuss with Ms. Jankowski other than that, I think everything has been handled.

Please note that I was not delinquent in my response to my inspection, and expunge any reference to that on my record, if that is applicable. As noted in my earlier letter, we have been in business for 80 years, and take pride in our product. Anything casting a doubt on that draws my full attention.

I thank you for your time, and look forward to my discussion with Ms. Jankowski. As always, the, ohservations of the FDA are appreciated, taken seriously, and addressed at once.



Michael Brede
Brede, Inc


July 14, 2008

Michael Brede
Brede, Inc.
19000 Glendale
Detroit, MI 48223

Department of Health and Human Services
Food and Drug Administration
300 River Place, Suite 5900
Detroit, MI 48207

Re: FEI NUMBER 181503.3 (6/13/2008 - 6/18/2008)

In response to OBSERVATIONS:

1. a. We fabricated 3 additional handles that will be kept in a specific container mounted on the wall. If one falls, it will go to the washing bin and a new one will be utilized. They will all be sanitized at end of every day's production.

All employees have again been strongly advised that fingers should never touch rims of jars where food may come in contact. Handlers also have begun wearing disposable gloves. Signs have been made and posted in production rooms reminding employees of cleanliness habits.

Hairnets Required in Production Room
No Smoking, Eating, Drinking in Production Room
Employees must wash Hands and wear Gloves
Sanitize all Utensils and Up Belt at end of EVERY day's production

1.b. Disposable glove dispenser installed at top of ladder for employees to put on to move rinsed roots around on the conveyor belt. Ladder handles will be wiped down with sanitizer.

Our employees DO wear uniforms: Girls have white coats and men have blue pants and shirts. They do not work in street clothes.

1.c. "Laboratory" room is really another Break Room for those employees that smoke. We took down the old "Laboratory" sign and replaced it with a "Break Room" sign, to eliminate confusion with inspectors. The cited empty containers were removed in front of FDA inspectors. The room is never used for any type of filling or labeling anymore.

2.a. Measuring cup for mustard oil is plastic and permanently stained. However, it is part of all utensils that are now being washed with [redacted] Food Grade Sanitizer everyday.

2.b. Interior surface of tumbler will be rinsed out before the first use of each production day, in addition to being cleaned at end of production day. The rough metal edge that was catching pieces of root was removed and the surface smoothed

2.c. Paddles are made of food grade rubber. Belt is hosed with hot water at end of each day, but [redacted] is now also used to further sanitize.

2.d. Opaque plastic drip trays replaced. Metal rack scrubbed with brillo pads and [redacted] Sanitizer to remove corrosion and debris. These are categorized as "utensils" that will be sanitized at end of each production day.

3. Canvas is being replaced correctly, with no "pocket" where roots can get trapped against housing. This is being done within the next two weeks.

4. Pesk Control Co., [redacted] installed "blue light" to control flying insects. New cleaning habits have already resulted in fewer observed flying insects near belt area.

5. In accordance with inspector, we agreed to never leave the hose in the drain after flushing water through.

6. Horseradish roots are refrigerated from the time they are harvested from the ground to my Refrigerator. This "fuzz" is normal and washes off completely in the tumbler machine.

7. Metal was smoothed post our conversation and tumbler will be rinsed before each day. Also, have found food grade [redacted]. It is applied through a spray container and once a week, we will spray tumbler, paddles and all other areas that show signs of discoloration, corrosion or wear.

Roots are aggressively rinsed and are properly clean after washing process.
We have never had product return or complaints because of spoilage or contamination in 80 years of business. We do take pride in our product and appreciate your observations and reminders to better our production practices.



Michael J. Brede