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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Twinam Enterprises, Inc. 26-Mar-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

555 Winderley Pl., Ste. 200

Maitland, FL 32751

VIA FEDERAL EXPRESS

WARNING LETTER

FLA-02-34

March 26, 2002

Mark A. Twinam, President and Owner

Twinam Enterprises, Inc.

d/b/a T.W. Wholesale

13613 Gulf Blvd.

Madeira Beach, Florida 33708

Dear Mr. Twinam:

We inspected your firm, located at 13613 Gulf Blvd., Madeira Beach, Florida 33708 on

February 5, 2002 and found that you have serious deviations from the Seafood HACCP

regulations (21 CFR Part 123). These deviations, which were previously brought to

your attention, cause your scombroid species fish, such as Amberjack and Mahi-Mahi,

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:

To comply with 21 CFR 123.6(b), you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur. However, your firm does not have and has not implemented a HACCP plan for scombroid species to control the histamine formation hazard. Specifically, the "model" HACCP plan you believe you obtained from one of your competitors was not modified to reflect your firm?s actual operations. It also fails to bear any firm or product identifiers, is not signed or dated and has not been implemented. You acknowledged to our investigator that your firm had not conducted a hazard analysis or completed development of a HACCP plan for scombroid species fish. This deviation was previously brought to your attention in our letter dated October 19, 2000.

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 such as a HACCP plan

consistent with your firm? s operations, monitoring or sanitation records and 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 Part

110). 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: Shari J.

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

If you have questions regarding any issue in this letter, please contact Ms. Hromyak at

(407) 475-4730.

Sincerely,

Emma R. Singleton

Director, Florida District