Inspections, Compliance, Enforcement, and Criminal Investigations
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
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
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
Emma R. Singleton
Director, Florida District