FDA EIR - ANHUI JINHE INDUSTRIAL CO.,LTD - January 14, 2020

An FDA inspection of ANHUI JINHE INDUSTRIAL CO.,LTD, a Chinese manufacturer and distributor of food additives, was conducted from January 13-14, 2020. This first-time inspection for the firm covered production, quality systems, materials, facilities, equipment, warehousing, and laboratory controls for products destined for the USA market. The regulatory framework for the inspection included Current Good Manufacturing Practices (CGMP) and Hazard Analysis, and Risk-Based Preventive Controls in Human Foods, under Compliance Program 7303.014. While no formal Form FDA 483 (Inspectional Observations) was issued, the FDA investigator verbally discussed three areas for improvement with the General Manager. These included the need to enhance a washing station in the Sucralose manufacturing area by adding alcohol for hand sanitization, improving the hand washing and sanitizing procedure near the packing area to establish a clear time for hand cleaning, and updating manufacturing process documents (e.g., for Sucralose) to ensure they contain complete approval and verification information. The company's management acknowledged these discussion items and committed to implementing the necessary corrections to maintain compliance with relevant regulations.