FDA WARNING_LETTER - Yichang Jiayuan Foodstuffs Co., Ltd - September 28, 2022

The FDA inspected a food manufacturing facility in Yichang, Hubei, China, from September 26-28, 2022, focusing on ready-to-eat (RTE) Mandarin Oranges in light syrup in glass jars. The inspection revealed a serious violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to the product being deemed adulterated under 21 U.S.C. § 342(a)(4).

The primary violation was the failure to appropriately evaluate the physical hazard of glass chips, which was identified in the hazard analysis but not determined to require a preventive control. During the inspection, the firm's (b)(4) machine, intended to detect glass fragments, failed a challenge test, indicating inadequate control procedures. The Corporate Quality Assurance Director also stated the machine had never been calibrated previously. Although the firm responded with corrective actions including machine calibration, employee training, and updated procedures, they did not provide a revised food safety plan addressing the lack of a preventive control for glass.

The FDA requires a written response within fifteen working days outlining specific corrective steps, including documentation and a timetable for implementation if actions extend beyond this period. Failure to adequately address these issues may result in regulatory action, including refusal of admission for imported products and placement on detention without physical examination (DWPE) under Import Alert #99-