Jug Creek Fish Company 11-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

555 Winderley Pl., Suite 200

Maitland, FL 32751

VIA FEDERAL EXPRESS

WARNING LETTER

FLA-01-17

December 11, 2001

Virginia Morton, President

Jug Creek Fish Company

16498 Tortuga Street

Bokeelia, Florida 33922

Dear Ms. Motion:

We inspected your fish processing facility located at 16498 Tortuga Street, Bokeelia,

Florida, on October 10, 2001. The inspection found that you have serious deviations

from the Seafood HACCP regulations (21 CFR Part 123). The deviation, which was

previously brought to your attention, causes scombroid fish (jack crevalle and fresh

mackerel) 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 home page at www.fda.gov.

The deviation is as follows:

You must have a written HACCP plan to control any food safety hazards that are

reasonably likely to occur to comply with 21 CFR 123.6(b). However, your firm

does not have a HACCP plan for scombroid species of fish to control the food

safety hazard of histamine formation.

We previously sent you an Untitled Letter dated March 6, 1998, which listed the failure

of your firm to have a HACCP plan for scombroid fish. We replied on April 16, 1998 to

your March 23, 1998 response, advising you of the inadequacies of your response. A

copy of the Untitled Letter and our April 16, 1998 response letter is enclosed for your

reference.

We may take further action if you do not promptly correct these violations. For instance,

we may take further action to seize your product(s) and/or enjoin your firm from

operating.

Please respond in writing within three (3) weeks from your receipt of this letter. Your

response should outline the specific things you are doing to correct these deviations.

You may wish to include in your response documentation of your HACCP plan for

scombroid species of fish or other useful information that would assist us in evaluating

your corrections. If you cannot complete all corrections before you respond, we expect

that you will explain the reason for the delay and state when you will correct any

remaining deviations.

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 regulations and the Good Manufacturing Practice regulations (21 CFR 11O).

You also have a responsibility to use procedures to prevent further violations of the

Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Timothy J.

Couzins, Compliance Officer, 555 Winderley Place, Ste. 200, Maitland, Florida 32751.

If you have questions regarding any issue in this letter, please contact Mr. Couzins at

(407) 475-4728.

Sincerely,

Emma R. Singleton

Director, Florida District