【排人墙阻止检查】日本精化遭FDA禁令+警告

Dear Mr. Kaneko:

On December 14, 2015, the U.S. Food and Drug Administration (FDA) arrived at your drug manufacturing facility, Nippon Fine Chemical Co., Ltd, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo, to conduct an inspection. The FDA investigator documented that your firm limited and/or refused an FDA inspection. Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), section 707, 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection. We reviewed your responses dated January 5, 2016, April 25, 2016, the two letters from August 18, 2016, and correspondence from counsel dated September 14, 2016, in detail.
2015年12月14日，FDA来到你们的药物制造工厂，位于兵庫県高砂市梅井5丁目1番1号的日本精化株式会社进行检查。 FDA检查员发现贵公司阻碍和/或拒绝FDA检查。根据FD&C法案FDASIA第707节，21 U.S.C. 351(j)，你们所生产、加工、包装的药品被认定为掺假并且在那个阻碍并拒绝检查的工厂的药品将被限制。我们审阅了你们于2016年1月5日和2016年4月25日的回复，收到2016年8月18日的两封来信，并2016年9月14日与律师进行了通信。

Your firm limited an inspection and/or refused to permit the FDA inspection as follows:贵公司阻碍检查和/或拒绝准许FDA检查的情况如下： 

1.     Barring access to areas 阻拦检查人员进入

During the inspection, your firm limited the investigator’s access to the quality control laboratory. The quality control manager directed employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution.
检查期间，贵公司阻碍检查人员进入质量控制实验室。质量控制经理带领员工排排站，阻拦我们的检查员访问部分实验室和用于分析药品的设备。 

2.     Refusal to provide copies of documents 拒绝提供文件复件

Your firm manufactures certain drugs for the Japanese and U.S. markets using the same equipment and processes, and divides lots for distribution between the two markets.

贵公司使用相同工艺和设备生产某一药品同时供应美国和日本市场，并分批配送。

During the inspection, our investigator reviewed complaints you received about your drugs from your customers, including complaints that your drugs contained glass, hair, cardboard, metal, product discoloration, and a black spider. Your firm limited the inspection by refusing to provide FDA copies of these records.

检查期间，我们的检查员审核了你们收到的药品的投诉，包括你们的药品有玻璃、毛发、纸板、金属、产品变色，和黑蜘蛛。贵公司拒绝向FDA提供这些记录的复件从而阻碍检查。

3.     Limiting photography 限制拍照

During the inspection, our investigator attempted to take pictures of the (b)(4) apparatus used to manufacture drugs for U.S. distribution. Your quality assurance manager impeded the inspection by preventing our investigator from photographing this piece of equipment.
检查期间，我们的检查员想要对 用于生产美国市场的药品的(b)(4) 装置进行拍照 。你们的质量保证经理妨碍我们的检查员对这台设备进行拍照，阻碍检查。

Your firm was placed on Import Alert 99-32 on August 8, 2016.

贵公司被列入2016年八月8日的进口警告99-32中。