FDA WARNING_LETTER - Two Amigos Import & Export Inc

On December 15, 2010, the FDA inspected Two Amigos Imports & Exports, Inc. in Miami, Florida, and found violations of the Public Health Service Act (PHS Act), Section 361, 42 U.S.C. 264. The company was offering live turtles with a carapace length of less than four inches for sale to retail customers as household pets.

This practice violates 21 CFR 1240.62(b), which prohibits the sale, holding for sale, or commercial/public distribution of viable turtle eggs and live turtles with a carapace length under four inches. Such turtles can carry and transmit Salmonella bacteria, causing salmonellosis, characterized by severe gastrointestinal symptoms and potential death. The facility's operations did not meet any exceptions listed in 21 CFR 1240.62(d) for scientific, educational, or exhibitional purposes.

The FDA requires the company to immediately cease selling and distributing undersized turtles. Prompt corrective action is necessary to prevent recurrence, and the company must establish procedures to ensure ongoing compliance. Failure to comply may result in further regulatory action. A written response detailing corrective steps, including documentation, is required within fifteen working days of receiving the letter. If corrections cannot be completed within this timeframe, the reason for delay and a new timeframe must be provided.