首页 > 资讯 > FDA与Downing实验室达成合意判决

出自识林

2016-01-13 FDA

美联邦法院对Downing实验室达成合意判决
德州配药房生产和销售违法药品
2016年1月11日

上周五，1月8日，美国联邦地区法院法官Sam A.Lindsay在美国政府和德州Dallas的Downing实验室公司和公司共同所有人Ashley Michelle Downing和Christopher Van Downing，和主管药剂师Roger E. Mansfield之间达成永久禁令之合意判决。

根据随合意判决提交的诉状，Downing实验室（原名Nu Vision药房）生产和销售的所谓的无菌药品是掺杂产品，因为这些药品在不卫生的环境中生产，并违反联邦食品、药品和化妆品法案（FD&C法案）要求的现行药品生产质量管理规范。

FDA药品审评和研究中心主任Janet Woodcook表示，“尽管多次警告该公司，Downing实验室继续在不卫生的环境下生产注射药品，将患者的健康和安全置于危险之中。FDA一直贯彻适当的和积极的行动以保护公众健康。”

美国司法部代表FDA开始行动。合意判决禁止Downing实验室和其所有人生产、持有或销售药品，直至其符合FD&C法案及其实施规范以及其它要求。

2013年4月，NuVision因缺乏无菌保障和与质量控制过程相关的担忧，召回甲钴胺注射剂和冻干针剂。召回之前，公司收到报告，患者在接受甲钴胺注射剂治疗后出现发烧、流感样症状以及注射部位疼痛。2013年7月和2014年9月，基于在2013年4月和2014年7月完成的FDA检查发现，FDA正式要求Downing实验室找回市场上所有未过期无菌产品，并警告医疗保健提供者和消费者不要使用这些产品。Downing实验室拒绝了FDA的召回要求。2015年6月，Downing实验室登记为外包设施。

最近，作为FDA于2015年10月结束的对Downing实验室检查中发现的严重缺陷的结果，因无菌保障和连续无菌操作的缺失，公司自愿对其所称的无菌药品采取全国范围的召回。缺陷包括注射剂药品微生物污染、无菌工艺区域清洁不充分，无菌操作不足。FDA检查员还确定Downing实验室销售药品的无菌检测失败。

Federal judge enters consent decree against Downing Labs
Texas compounder manufactured and distributed drug products in violation of law
For Immediate Release January 11, 2016 原文地址

On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.

According to the complaint filed with the consent decree, Downing Labs (formerly known as NuVision Pharmacy) manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

“Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA pursued appropriate and aggressive action to protect the public health.”

The U.S. Department of Justice brought the action on behalf of the FDA. The consent decree prohibits Downing Labs and its owners from manufacturing, holding or distributing drugs until they comply with the FD&C Act and its regulations, in addition to other requirements.

In April 2013, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with quality control processes. Prior to the recall, the company received reports that patients had experienced fever, flu-like symptoms, and soreness at the injection site after receiving methylcobalamin injections. In July 2013 and September 2014, based on findings from the FDA’s inspections ending in April 2013 and July 2014, the FDA formally requested that Downing Labs recall all of its unexpired sterile products on the market, and warned health care providers and consumers against their use. Downing Labs refused FDA’s requests to recall. In June 2015, Downing Labs registered as an outsourcing facility.

Most recently, as a result of serious deficiencies identified by the FDA during an inspection of Downing Labs ending in October 2015, the company voluntarily conducted a nationwide recall of its purportedly sterile drug products due to a lack of sterility assurance and ceased sterile operations. The deficiencies included microbial contamination of injectable drug products, inadequate cleaning and sanitization of sterile processing areas, and inadequate sterile practices. FDA investigators also determined that Downing Labs distributed drug products that failed sterility testing.