Inspections, Compliance, Enforcement, and Criminal Investigations
J.MC. Ltd./Racconto 23-Nov-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
300 S. Riverside Plaza, Suite 550 South
Chicago, Illinois 60606
November 23, 2001
RETURN RECEIPT REQUESTED
Mr. Lee N. Mugnolo, President/CEO
J.M.C. Ltd. d.b.a. Racconto
2000 Hawthorne St.
Melrose Park, IL 60160
Dear Mr. Mugnolo:
On August 3, 7, and 9, 2001, the Food and Drug Administration (FDA) conducted an
inspection of your facility. The inspection was conducted to determine your compliance
with FDA?s seafood processing regulations (Title 21, Code of Federal Regulations (CFR), Part 123).
The seafood processing regulations, which became effective on December 18, 1997,
require that you have and implement written verification procedures to verify that your
foreign suppliers have implemented a preventive system of food safety controls known as
Hazard Analysis Critical Control Point (HACCP) in accordance with U.S. requirements.
These verification procedures must include product specifications to preclude safety
hazards and at a minimum one or more affirmative steps [21 CFR 123.12(a)(2)(ii)].
Affirmative steps may include the following:
(A) Obtain from the foreign processor the HACCP and sanitation monitoring records
that relate to the specific lot offered for import;
(B) Obtain either a continuing or lot-by-lot certificate from an appropriate foreign
government or third party;
(C) Regularly inspect the foreign processor?s facilities;
(D) Maintain on file a copy, in English, of the foreign processor?s HACCP plan, and a
written guarantee from the foreign processor that the imported fish or fishery
product was processed in accordance with seafood HACCP;
(E) Periodically test the imported fish or fishery product, and maintain on file, in
English, a written guarantee from the foreign processor that the imported fish or
fishery product was processed in accordance with seafood HACCP; and
(F) Other such verification measures as appropriate that provide an equivalent level
of assurance of compliance with the requirements of this part.
These are the kinds of measures that prudent importers already take. HACCP provides a
systematic way of taking measures that demonstrate to FDA, to your customers, and to
consumers that you purchase your imported seafood products from foreign suppliers who
routinely practice seafood safety by design, and are in compliance with the U. S. food
laws and regulations.
During our inspection, the FDA investigator observed shortcomings in your verification
procedures that, upon our preliminary review, appear to be deviations from the requirements of the Seafood HACCP regulations. The FDA investigator also provided
you with a copy of the Import Seafood HACCP Report (form FDA 3502), which presents
his evaluation of your firm?s performance regarding various aspects of the HACCP
requirements. The observations of concern to us are as follows:
You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR
123. 12(a)(2)(i). However, your firm does not have a product specification for
Anchovies in oil imported from [redacted].
You must implement, document, and maintain records of an affirmative step which
ensures that the fish and fishery products you import are processed in accordance
with the seafood HACCP regulations, to comply with 21 CFR 123. 12(a)(2)(ii) and
(c). However, your firm did not perform or document an affirmative step for
Anchovies in oil manufactured by one [redacted] supplier.
In addition, the investigator?s inspection of your "vinegar" packing operation determined
that you were bottling glacial acetic acid, diluted with water to 5%, and labeling it as
"WHITE VINEGAR style." Diluted acetic acid is not vinegar and would be considered
misleading if so labeled. I have enclosed the FDA policy statement regarding this matter.
We encourage you to make the necessary improvements as soon as possible. However, if
you disagree with FDA?s assessment, you should explain how your system is complying
with the regulations. We understand that there may be more than one way to verify
compliance with the Seafood HACCP regulations. In either case, you should respond to
this office on this matter within 30 working days of the receipt of this letter. Upon receipt
of your response, we will work with you to resolve any outstanding issues associated
with your verification plan. In addition, please include any corrective action(s) such as
new labeling or procedures you are/will employ in bottling "vinegar." If we do not hear
from you, or if your response is inadequate, we will assume that our preliminary
conclusions are correct and we will schedule a follow-up inspection for the immediate
Your reply relating to these concerns should be directed to Paul A. Boehmer, Compliance
If you have any questions regarding the implementation of the HACCP regulations, you
may contact Darrell Luedtke at our Gurnee, Illinois office, telephone (847) 249-8632, for
answers and/or direction towards guidance and sources of training in achieving
We look forward to working with you to achieve a successful HACCP program.
Raymond V. Mlecko