Yuyao City Boss Vegetable Factory Co., Ltd. – FDA Warning Letter, Jun 17, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Yuyao City Boss Vegetable Factory Co. Ltd. following an inspection conducted from June 16 to June 17, 2025. The inspection revealed serious violations of federal regulations for Emergency Permit Control and Acidified Foods (21 CFR Parts 108 and 114). The main issue was the company's failure to maintain accurate processing and production records, demonstrating adherence to their scheduled processes for acidified mustard stems. Investigators observed staff fabricating and backdating numerous critical monitoring records during the inspection, covering production since 2023. This indicated the company could not ensure its products were manufactured according to established safety processes. Consequently, FDA placed the company’s acidified mustard stem products on Import Alert #99-38, resulting in detention without physical examination for U.S. imports, as these violations render the products adulterated. The company's initial response was deemed inadequate. Yuyao City Boss Vegetable Factory Co. Ltd. is required to notify the FDA within fifteen working days of specific corrective steps, providing supporting documentation, including processing records for multiple product lots. The FDA strongly recommends engaging a qualified consultant to conduct a comprehensive audit and ensure compliance with Current Good Manufacturing Practices to resolve these significant issues.