106－108年度美國食品藥物管理局境外查核我國食品加工廠衛生安全管理之查核摘要分析

Analysis on USFDA Foreign Food Facility Inspection Program for Food Safety and Sanitation Management Facilities in Taiwan from 2017 to 2019

陳家慧(CHIA-HUI CHEN) ； 楊雅珺(YA-CHUN YANG) ； 陳美娟(MEI-CHUAN CHEN) ； 林旭陽(HSU-YANG LIN) ； 劉芳銘(FANG-MING LIU)

《食品藥物研究年報》 11期 (2020/12) Pp. 275-285

摘要

為確保進口食品衛生安全，歷年來美國食品藥物管理局（U.S. FDA）針對進口國食品工廠進行實地查核。近年因應美國食品安全現代化法案及其相關規則的公告與執行，U.S. FDA來臺查核我國食品加工廠之工廠類型越趨多元，並針對部分食品工廠新增以「食品安全預防控制（Preventive Controls for Human Food, PC）」為查核重點，包含分析天然及人為之潛在危害風險、建立各階段各層面預防性管制措施，以落實源頭管理、製程管控與消費者保護機制，並輔以人員專業培訓確保管制措施之實行，為消費者食用安全衛生把關。本文綜整106年至108年度U.S. FDA來臺實地查廠之查核資訊，並分析U.S. FDA對我國食品加工廠提出之觀察事項與改善建議，以了解美國稽查實務管理概況。

關鍵字

美國食品藥物管理局 ； 食品安全預防控制（PC） ； 稽查

並列摘要

The on-site inspection of foreign food facilities conducted by U.S. Food and Drug Administration (U.S. FDA) is designed to ensure the safety of imported foods. Based on the announcement and implementation of the U.S. Food Safety Modernization Act (FSMA) and related regulations in recent years, the types of food facilities which the U.S. FDA inspected are becoming more diverse and the inspection days of some facilities can extend up to 5 days due to the newly added rule of ＂Preventive Controls for Human Food (PC).＂ The inspection point of PC is to implement source management, process control and consumer protection mechanisms by analyzing natural and man-made potential hazards and establishing various levels of control measures, supplemented by professional staff training to ensure the implementation of control measures. This report summarizes the inspection results of the onsite inspection conducted by the U.S. FDA in Taiwan from 2017 to 2019, and analyzes the U.S. FDA's observations and suggestions the for the improvement of food facilities.

並列關鍵字

Food and Drug Administration (U.S. FDA) ； Preventive Controls for Human Food (PC) ； inspection