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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Schafer Fisheries, Inc. 8/5/09


hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

August 5, 2009




Mr. Michael J. Schafer
Schafer's Fisheries, Inc.
2112 Sandridge Rd.
Thomson, Illinois 61285

Dear Mr. Schafer:

We inspected your seafood processing and distributing facility, located at 2112 Sandridge
Rd., Thomson, IL on May 20 and 21, 2009. We found that you have serious violations of
the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21,
Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice
regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and
110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery
products to have and implement a HACCP plan that complies with this section, or
otherwise operate in accordance with requirements of Part 123, renders the fish or fishery
products 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). Accordingly, your herring roe products
are adulterated in that they have been prepared, packed, or held under insanitary
conditions whereby they may have become contaminated with filth, or whereby it may
have been rendered injurious to health. You may find the Act, the seafood HACCP
regulations and the Fish and Fisheries Products Hazards & Controls Guidance through
links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must conduct a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur and have a written HACCP
plan that, at a minimum, lists the food safety hazards that are reasonably likely
to occur, to comply with 21 CFR 123.6 (a) and (c) (I). A food safety hazard
is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical
property that may cause a food to be unsafe for human consumption."
However, your firm's HACCP plan for fish roe from various types of freshwater fish does not list the food safety hazard of pathogen growth particularly the potential for Clostridium botulinum growth.

2. You must maintain sanitation control records that, at a minimum, document
monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21
CFR 123.11(c). However, your firm does not document the sanitation
monitoring activities conducted at your firm. Specifically, your firm did not
maintain sanitation monitoring records and corrections of sanitation
deficiencies for the safety of water used to manufacture ice, condition and
cleanliness of food contact surfaces, prevention of cross-contamination from
insanitary objects, maintenance of hand washing, hand sanitizing, and toilet
facilities, storage and use of toxic chemicals, control of employee health
conditions, and exclusion of pests at your facility.

We may take further action if you do not promptly correct these violations. For instance,
we may take further action to seize your products and/or enjoin your fum from
distributing violative products in interstate commerce.

You should respond in writing within (15) working days from the receipt of this letter.
Your response should outline the specific actions you are taking to correct these
deviations. You should include in your response documentation such as HACCP and
verification records, 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

This letter may not list all the deviations at your facility. You are responsible for
ensuring that your processing plant operates in compliance with the Act, the seafood
HACCP regulation (21 CFR 123) and the current Good Manufacturing Practices (21 CFR
Part 110). You also have a responsibility to use procedures to prevent further violations
of all applicable regulations.

Your response should be directed to: Rosemary Sexton, Compliance Officer, Food and
Drug Administration, 550 West Jackson Boulevard, 16th Floor, Chicago, IL 60661-5800.
If you have any questions regarding any issues in this letter, please contact Ms. Sexton at



Scott J. Maclntire
District Director