FDA WARNING_LETTER - Choo's Enterprises Ltd - March 06, 2024

On June 3, 2024, the FDA issued a Warning Letter to Choo's Enterprises Ltd. in Barbados, following an inspection from March 4-6, 2024. The inspection revealed serious violations of the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114).

The primary violation cited was the failure to provide the FDA with scheduled processes for acidified food products, including Windmill Baxter's Road Seasoning, Windmill Classic Mauby Syrup, Sweet & Tasty Mauby Syrup, Sugar Free Mauby Syrup, Ginger Beer Syrup, and Sugar Free Ginger Beer. This is required by 21 CFR 108.25(c)(2) and 21 CFR 114.83, which mandates that scheduled processes be established by a qualified person and submitted on Form FDA 2541e. The company's April 4, 2024, response, which included a training record and photographs, was deemed inadequate as it did not confirm plans to file the required scheduled processes.

Failure to comply with these regulations renders the acidified food products adulterated under section 402(a)(4) of the Act. The FDA stated that without scheduled processes on file, the company's acidified food products would be refused admission into the United States under section 801