Inspections, Compliance, Enforcement, and Criminal Investigations
Big Bay De Noc Fisheries, Inc 22-Jan-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
1560 East Jefferson Avenue
Detroit, Ml 48207-3179
RETURN RECEIPT REQUESTED
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.
David Kaszubski for Joann M. Givens