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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Big Bay De Noc Fisheries, Inc 22-Jan-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Detroit District

1560 East Jefferson Avenue

Detroit, Ml 48207-3179

Telephone: 313-226-6260

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

2002-DT-20

January 22, 2002

Mr. Michael J, Hermes, President/Vice-President

MI-,James P. Hermes, Secretary/Treasurer

Big Bay De Noc Fisheries, Inc.

Vans Harbor Road

Garden, MI 49835

Dear Messrs. Hermes:

On August 27th ? 28th, 2001 the Food and Drug Administration (FDA) conducted an

inspection of your facility located at Vans Harbor Road, Garden, MI. The inspection was

conducted to determine compliance with the FDA?s Seafood Hazard Analysis Critical

Control Point (HACCP) Regulation(21 CFR 123) and the current Good Manufacturing

Practice requirements for foods (GMP) (21 CFR 110).

During the inspection, the FDA investigator observed shortcomings in your system that

are serious deviations from the principles of HACCP and the significant requirements of

the program. These deviations, some of which were previously brought to your attention,

cause your whitefish roe and chub roe products to be in violation of section 402(a)(4) of

the Federal Food, Drug and Cosmetic Act. You can find this Act and the seafood

HACCP regulations through links in FDA?s homepage www.fda.gov.

These deviations were as follows:

1. You must have a HACCP plan that lists the critical limits that must be met, to comply

with 21 CFR 123.6(c)(3). However, your firm?s HACCP plan for whitefish roe and

chub roe lists a critical limit, maximum eater phase salt, at the brining critical control point that is not adequate to control the food safety hazard of Clostridium botulinum toxin formation. In order to control Clostridium botulinum toxin formation at the brining step you must ensure a minimum water phase salt of 5%.

You should be aware that if your roe products are immediately frozen after processing, maintained frozen throughout distribution, and labeled "Important, keep frozen until used, thaw under refrigeration immediately before use," formation of Clostridium botulinum toxin may not be a significant hazard. Please refer to Chapter 13 in the FDA Fish & Fisheries Products Hazards & Controls Guidance, Third Edition, June 2001.

2. You are required to have sanitation control records that document monitoring and

corrections, in order to comply with 21 CFR 123.11(c). However, you failed to

maintain sanitation control records for all 8 required sanitation steps with a sufficient

frequency. For example, the last available "Daily Sanitation Audit Form" was dated

9/27/99 and only half of the listed "sanitation conditions" had been monitored.

The above-identified deviations 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.

You should take prompt measures to correct these deviations. Failure to promptly correct

the deviations noted may result in regulatory action without further notice. Such action

includes seizure or injunction.

Please notify this office in writing, within fifteen(15) working days of receipt of this

letter, of the specific steps you have taken to correct these violations, including an

explanation of each step taken to prevent their reoccurrence. If corrections cannot be

completed within 15 working days, state the reason for the delay and the time frame

within which the corrections will be completed, Also, please include copies of any

available documentation demonstrating that corrections have been made.

Your written reply should be directed to David M. Kaszubski, Director Compliance

Branch, U.S. Food and Drug Administration, 1560 E. Jefferson, Detroit, MI 48207,

telephone (313) 226-6260 ext. 185.

Sincerely,

David Kaszubski for Joann M. Givens

District Director

Detroit District