FDA WARNING_LETTER - DALAI BIOTECH COMPANY LTD - May 27, 2024

On May 24-27, 2024, the FDA inspected the acidified food facility of 10 Minzhi Rd. Tongluo Township, Miaoli County, Taiwan, finding serious deviations from 21 CFR Part 108 (Emergency Permit Control) and 21 CFR Part 114 (Acidified Foods). The firm manufactures fruit-flavored popping boba pearls for export to the U.S.

Significant violations include: 1. **Failure to Register as a Food Canning Establishment (FCE):** The firm did not register with the FDA via Form FDA 2541 within 10 days of commencing operations, as required by 21 CFR 108.25(c)(1). As of September 10, 2024, the firm continues to ship products to the U.S. without FCE registration. 2. **Failure to File Scheduled Processes:** The firm has not provided scheduled process information for any of its acidified food products (e.g., strawberry, peach, mango boba pearls) to the FDA via Form FDA 2541e, as required by 21 CFR 108.25(c)(2). 3. **Lack of Qualified Process Authority and pH Control:** The firm's manager stated no scheduled process was established by a qualified person (21 CFR 114.8