Warning Letter 320-16-35
Via UPS
Return Receipt Requested
September 26, 2016
Mr. Hiromichi Kaneko
General Manager
Nippon Fine Chemical Co., Ltd
1-1, 5-Chome, Umei
Takasago City, Hyogo 676-0074
Japan
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.
在2015年12月14日，美国FDA官员抵达日本精化株式会社的所在地核查，FDA检察员证实你们的工厂限制或拒绝FDA的核查。根据《联邦食品、药物和化妆品法》和修正后的《食品和药品管理局安全与创新法案》，你们的药物在生产、加工、包装和储存中参杂使假并限制或拒绝核查。
Your firm limited an inspection and/or refused to permit the FDA inspection as follows:
1. Barring access to areas
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.
阻止进入特定区域
核查过程中，你们的工厂限制检察员进入质量控制实验室，质量控制经理指挥员工肩并肩站立，阻止检察员进入部分用于分析供应美国市场药物的实验室及其设备。
2. Refusal to provide copies of documents
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. 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.
拒绝提供文件副本
你们为日本和美国市场生产的特定药品使用同一设备和工艺，在两个市场使用不同的批号。核查过程中，我们的检察员复查了客户关于你们的药品的投诉，包括你们的药品中含有玻璃、头发、硬纸板、金属、未脱色的产品以及一只黑色的蜘蛛，你们的工厂拒绝提供这些记录的副本。
3. Limiting photography
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.
限制拍照
核查过程中，我们的检察员试图给用于美国市场的药物生产设备拍照，你们的QA经理阻碍了拍照。
Your firm was placed on Import Alert 99-32 on August 8, 2016.
The violations cited in this letter are not intended to be an all-inclusive list. You are responsible for investigating and determining the causes, for preventing their recurrence, and for preventing the occurrence of other violations.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, this office may recommend withholding approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Nippon Fine Chemical Co, Ltd, Takasago City, into the United States are subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
After you receive this letter, respond to this office in writing within 15 working days.
Send your electronic reply to or mail your reply to:
LaKeesha M. Foster, Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Ave
Silver Spring, MD 20993
USA
Please identify your response with FEI 3001722961.
Sincerely,
/S/
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
（来源：FDA官网，翻译：医药与化工）
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