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The US Food and Drug Administration, FDA, has added six Asian drug manufacturers to its import alert list this month, that refused a planned inspection of the FDA. 美国食品和药物管理局（FDA）本月在其进口警示名单中增加了六家亚洲药品制造商，拒绝FDA进行检查。
The newly listed Asian manufacturers are from China (4), India (1) and South Korea (1): 新增的进口警示亚洲制造商来自中国（4），印度（1）和韩国（1）：
Chifeng Wanze Pharmaceutical Co., China 赤峰市万泽药业股份有限公司，中国 Guangdong Jiaying Pharmaceutical, Ltd., China 广东嘉应制药股份有限公司，中国 Shenyang Funing Pharmaceutical Co., China 沈阳福宁药业有限公司，中国 Guangdong Guangliang Industry Co., China 广东广粮实业有限公司，中国 Gpt Pharmaceuticals Private, India 印度Gpt制药有限公司，印度 Dongkook Pharmaceutical Co., South Korea 韩国东国制药株式会社，韩国
The so called “Red List” identifies firms that have offered FDA-regulated articles for import into the United States and yet refused to allow the completion of an FDA inspection of their foreign establishment for the purpose of determining its conditions and compliance with applicable laws and regulations. Refusing to permit entry or inspection through FDA’s personnel always leads to the impression that something is wrong. It is furthermore strongly suspected that the products manufactured, processed or packaged are adulterated. 所谓的“红名单”罗列了那些药品销至美国，但拒绝FDA检查的公司。拒绝允许FDA的人员进入或检查会导致出现问题。此外，强烈怀疑制造，加工或包装的产品是掺假的。
The reasons why these pharmaceutical manufacturers refused the inspections is still unknown. 这些制药厂商拒绝检查的原因尚不清楚。
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发表于 2018-9-11 09:13:23
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发表于 2018-9-11 09:37:13
