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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Filo Corporation 17-Jan-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

555 Winderiey Pl., Ste. 200
Maitland, FL 32751


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-06-11

January 17, 2006

Diego A. Lobato, President
Filo Corporation
D/b/a Turtle Mania
208 Three Islands Blvd, #101
Hallandale Beach, FL 33009

Dear Mr. Lobato:

Our office recently received a complaint that your business, Filo Corporation, d/b/a Turtle Mania, has been offering for commercial distribution live turtles with a carapace length of less than four inches to retail customers as household pets. On October 6, 2005, we inspected Turtle Mania's retail Kiosk located within the Fort Lauderdale Swap Shop, 3291 West Sunrise Blvd., Fort Lauderdale, Florida 33311. We observed your business offering live turtles with a carapace length of less than four inches to retail customers as pets. This is a serious violation of the Public Health Service (PHS) Act, Section 361 [42 U.S.C. 264]. Your practice of selling undersized turtles is not in conformance with Title 21, Code of Federal Regulations, Part 1240.62 [21 CFR 1240.62]. You may find this regulation and other information regarding the sale of turtles through links in the Food and Drug Administration's (FDA) home page at www.fda.gov.

The regulation specifies that viable turtle eggs and live turtles with a carapace length of less than four inches shall not be sold, held for sale, or offered for any type of commercial or public distribution. Turtles of this size may carry Salmonella bacteria and transmit these bacteria to humans, causing salmonellosis. Salmonellosis is characterized by severe gastrointestinal symptoms (abdominal pain, nausea, fever, and diarrhea) and occasionally results in death. The ban applies to these small turtles because they are most likely to be held for sale or used as children's pets and the purpose of the ban is to protect the public, primarily children, from turtle-associated salmonellosis.

Specifically, the complaint we received involved a young child requiring medical care for signs and symptoms of salmonellosis after playing with undersized turtles purchased from Turtle Mania. A laboratory sample taken by the pediatrician's office confirmed Salmonella bacteria.

As you were informed by our Investigator and our Supervisory Investigator in separate phone conversations, the regulations permit sales of turtles and turtle eggs for use in bona fide scientific, education or exhibitional purposes other than as pets. We are aware of your firm's implementation of a waiver statement signed by consumers purchasing illegal, undersized turtles stating that the turtles would only be used for scientific, educational, or exhibition purposes. Even with this statement, it is clear that your firm has been selling, holding for sale, and/or offering for distribution undersized turtles as pets. For example, you were operating at a retail location. As such, your firm's activities do not meet the scientific, educational, or exhibition purposes exemption.

The above is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that your operations are in compliance with the law. Selling, holding for sale, and/or offering for any other type of commercial or public distribution of turtles in violation of the PHS Act and 21 CFR 1240.62 may result in further regulatory enforcement action without further notice.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct this violation, including an explanation of each step taken to prevent reoccurrence. If correction cannot be completed within 15 working days, your response should state the reason for the delay and the time frame within which the correction will be completed.

Your reply relating to these concerns should be directed to the Food and Drug Administration, Attention: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, you may contact Ms. Shambaugh by telephone at (407) 475-4730.

Sincerely,

/S/

E'rnma R. Singleton
Director, Florida District