Inspections, Compliance, Enforcement, and Criminal Investigations
Two Amigos Import & Export Inc 2/14/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
February 14, 2011
Mr. Jose I. Salmeron
Two Amigos Imports & Exports, Inc.
4495 NW 73rd Avenue
Miami, Florida 33166
Dear Mr. Salmeron:
On December 15, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your business Two Amigos Imports & Exports, located in Miami, Florida. This letter notifies you of the violations of the Public Health Service Act (the PHS Act), Section 361, 42 U.S.C. 264. You may find this regulation and other information regarding the sale of turtles through links on the Food and Drug Administration’s home page at www.fda.gov.
We found that you offered live turtles with a carapace length of less than four inches for sale to retail customers as household pets. Under section 361 of the PHS Act, 42 U.S.C. 264, FDA is responsible for regulations to prevent the introduction, transmission, or spread of communicable diseases. Your practice of selling undersized turtles violates Title 21, Code of Federal Regulations (CFR), Part 1240.62(b) (21 CFR 1240.62(b)).
21 CFR 1240.62(b) 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 other 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 such as, abdominal pain, nausea, diarrhea, fever, and occasionally results in death.
21 CFR 1240.62(d) excepts certain sales of turtles and turtle eggs from the general prohibition, for example, the sale of turtle eggs or live turtles for bona fide scientific, educational, or exhibitional purposes, other than as pets. Your facility’s operations fail to meet any exception listed in 21 CFR 1240.62(d). Therefore, these sales and any continued sale of turtles with a carapace length of less than 4 inches are in violation of 21 CFR 1240.62(b).
The above is not intended to be an all-inclusive list of violations. As a distributor of animals offered as pets, you are responsible for ensuring that your overall operation is in compliance with the law.
We request that you immediately cease the selling and further distribution of turtles with a carapace length of less than four inches at your store or any retail location.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Carla Norris, Compliance Officer, at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Ms. Norris at (407) 475-4730.
Emma R. Singleton
Director, Florida District