FDA EIR - Hebei Yuxing Bio-engineering Co., Limited - May 17, 2018

An FDA inspection of Hebei Yuxing Bio-Engineering Co., Ltd. in China was conducted from May 16-17, 2018. The inspection, guided by regulatory frameworks for Preventive Controls in Human Foods and Domestic Food Safety, focused on the manufacturing and distribution of Vitamin B-12 products. The company received two formal observations documented on Form FDA 483. The main issues included inadequate cleaning and maintenance of food-contact and non-contact surfaces, with debris found on equipment such as transportation containers, millers, and sieves. Additionally, the Betain ingredient storage and mixing building was deemed structurally insufficient, failing to prevent pest and cross-contamination due to unscreened gaps, pest presence, damaged ingredient bags, and standing water. Verbal deficiencies highlighted a lack of current Good Manufacturing Practices (21 CFR Part 117) training, unsanitary bathroom conditions (lacking soap/hand dryers), reuse of contaminated single-use bags, debris in floor cracks, unscreened warehouse doors, and insufficient temperature control during product distribution, despite specific storage requirements. Company management committed to submitting a written response to the FDA 483 observations within 15 business days and establishing a corrective action plan for the verbal deficiencies.