近日，FDA 宣布扩大对国外食品、药品及医疗产品制造工厂的不预先通知检查（突击检查或飞行检查）范围，旨在消除双重标准，使外国公司与美国国内公司接受同等监管。FDA 还将改进相关政策和做法，明确检查人员需拒绝受监管企业提供的差旅住宿，以维护监督公正性。

 

原文及翻译如下

 

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

 

美国食品药品监督管理局宣布扩大对国外制造工厂的不预先通知检查的使用范围

 

Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.

 

今天，FDA宣布将扩大对食品、基本药物和其他医疗产品的国外制造工厂进行不预先通知检查的范围。这一变化是基于该机构在印度和中国的检查和调查办公室的国外不预先通知检查试点项目，旨在确保外国公司受到与国内公司相同水平的监管监督和审查。

 

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, M.D, M.P.H.

 

“长期以来，外国公司一直享受双重标准 —— 在工厂检查前收到预先通知，而美国制造商则在没有此类通知的情况下被要求达到严格的标准。这种情况从今天起结束。这是 FDA 在使国外检查重回正轨的更广泛战略中的关键一步，” 美国食品药品监督管理局局长马丁・A・马卡里医学博士、公共卫生硕士说。

 

In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for - hire vehicle transit), to maintain the integrity of the oversight process.

 

此外，FDA 将评估该机构的政策和做法，以改进国外检查计划，确保 FDA 成为监管监督的黄金标准。这些变化将包括明确 FDA 检查人员拒绝受监管企业提供的差旅住宿的政策，包括住宿和交通安排（出租车、豪华轿车和租车运输），以维护监督过程的完整性。

 

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.

 

FDA 每年在 90 多个国家进行约 12,000 次国内检查和 3,000 次国外检查。美国制造商经常接受不预先通知的检查，而外国公司通常有几周的时间准备，这破坏了监督过程的完整性。尽管外国公司收到了预先通知，但 FDA 发现严重缺陷的频率仍然是国内检查的两倍多。

 

Only in specific programs and cases are the FDA’s domestic inspections pre - announced to assure that appropriate records and personnel will be available during the inspection. But regulated companies do not have the authority to negotiate the day or time of the inspection— nor should foreign companies have the capability to do so either.

 

只有在特定的计划和情况下，FDA 的国内检查才会预先通知，以确保在检查期间有适当的记录和人员在场。但受监管的公司无权协商检查的日期或时间 —— 外国公司也不应该有这样的权利。

 

With this shift, the FDA is further ensuring that every product entering the U.S. is safe, legitimate, and honestly made. Unannounced inspections will also help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk. The FDA is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.

 

通过这一转变，FDA 进一步确保进入美国的每一种产品都是安全、合法和诚信制造的。不预先通知的检查还将有助于在不良行为者（那些伪造记录或隐瞒违规行为的人）危及美国人的生命之前揭露他们。FDA 有权对任何试图拖延、拒绝或限制检查，或拒绝允许进行不预先通知的药品或器械检查的公司采取监管行动。

 

“The FDA’s rigorous, science - based global inspections of manufacturing facilities ensure that the food and drug products that enter the U.S. marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said FDA Assistant Commissioner for Inspections and Investigations Michael Rogers. “These inspections provide real - time evidence and insights that are essential for making fact - based regulatory decisions to protect public health.”

 

“FDA 对制造工厂进行的严格的、基于科学的全球检查确保了进入美国市场和美国消费者家庭的食品和药品是安全、可靠且可获取的，”FDA 负责检查和调查的助理局长迈克尔・罗杰斯说。“这些检查提供了实时证据和见解，对于做出基于事实的监管决策以保护公众健康至关重要。”

 

The FDA’s global inspections generate real - time intelligence that strengthens enforcement and keeps American families safe. Every inspection goes through a classification assignment process to enable an appropriate regulatory response. Even inspections that yield a “No Action Indicated” provide important regulatory intelligence that strengthens the safety net for American consumers.

 

FDA 的全球检查生成实时情报，加强了执法力度，保障了美国家庭的安全。每次检查都要经过分类分配过程，以便做出适当的监管反应。即使是得出 “无需采取行动（NAI）” 结论的检查也能提供重要的监管情报，加强了美国消费者的安全保障。

 

This expanded approach marks a new era in FDA enforcement—stronger, smarter, and unapologetically in support the public health and safety of Americans.

 

这种扩大的检查方式标志着 FDA 执法进入了一个新时代 —— 更强大、更明智，并且毫不含糊地支持保障公众的健康和安全。

来源：Internet

关键词： 食品 药品 医疗产品 生产设施