Kimball Foods, Inc. 08-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Chicago District

300 S. Riverside Plaza, Suite 550 South

Chicago, Illinois 60606

Telephone: 312-353-5863

November 8, 2001

WARNING LETTER

CHI-7-02

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Eung Chul Kim, President

Kimball Foods, Inc

3445 N. Kimball Ave.

Chicago, IL 60618-5516

Dear Mr Kim:

An investigator from the Food and Drug Administration conducted an inspection at your

seafood processing facility on September 24, 25, and 26, 2001

The inspection found that you have serious deviations from the seafood HACCP Hazard

Analysis Critical Control Point) regulations (Title 21, Code of Federal Regulations (CFR), Part 123). These deviations, some of which were previously brought to your

attention, cause the mackerel products prepared, packed, or held at our facility to be

adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug. and

Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations

through links in FDA?s home page at wwv.fda.gov.

The deviations are as follows:

You have no HACCP plan for unfrozen mackerel that you process. You must have a

HACCP plan to control any food safety hazard(s) that are reasonably likely to occur.

However, your firm does not have a HACCP plan for mackerel to control the food safety

hazard of histamines.

There are intervals during which monitoring records (temperature/ice) are not kept. For

instance, there are intervals exceeding 2 days at times with no assurance products did not

exceed critical limits for scombrotoxin formation.

The above violations are not intended to be an all-inclusive list of deficiencies at your

facility. It is your responsibility to assure that your establishment is in compliance with

all requirements of the federal regulations. Moreover, it is your responsibility to produce

safe products. You should take prompt action to prevent further violation of the Act.

Further violation of the Act may result in regulatory action without further notice, which

can include seizure of your products and/or injunction of your firm.

You should have your process, procedures, and necessary documents examined by a

qualified Seafood HACCP individual to determine the HACCP requirements for

scombrotoxin fish so that steps can be taken to develop a plan and perform the necessary

HACCP operations to be in compliance with 21 CFR Part 123. It is essential that you

respond to this office concerning this matter within 15 days of receipt of this letter,

stating the specific steps you have taken to correct the noted violations. If corrective

action cannot be completed within 30 days, state the reasons for the delay and the time at

which the corrections will be completed.

Your reply should be directed to Paul Boehmer, Compliance Officer, at the above

address.

Sincerely,

\s\

Raymond V. Mlecko

District Director