FDA对专业药房的483缺陷表警告信药房的回复信FDA关闭信和企业检查报告

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VELLA OF DEER VALLEY, INC.是位于美国亚利桑那州凤凰城的一家专业药房，专门针对老年病，特种病进行个体化治疗的药房。可以根据处方配置无菌注射剂。
这里收集了美国FDA对该药房现场检查后发出的483缺陷表，警告信，药房的回复信，FDA关闭信和企业检查报告。比较完整地反应了FDA对企业进行GMP监理的互动过程。
英文版，供同仁们参考。
附件清单：
2013-02-19 至 2013-02-25  FDA现场检查
2013-02-25  FDA检查员签发483缺陷表
2013-03-7   FDA收到整改方案
2014-2-10   回复警告信
2015-07-20至2015-07-29 FDA现场检查
2015-07-29 FDA检查员签发483缺陷表
2015-07-31 FDA检查员签发又一张483缺陷表
2017-01-17 FDA发出警告信
2017-02-03 FDA发出关闭信
2017-08-23 FDA发出企业检查报告EIR
Specialty Pharmacy
A pharmacy that dispenses generally low volume and high cost medicinal preparations to patients who are undergoing intensive therapies for illnesses that are generally chronic, complex and potentially life threatening. Often these therapies require specialized delivery and administration.
Specialty pharmacy is defined as the service created to manage the handling and service requirements of specialty pharmaceuticals, including dispensing, distribution, reimbursement, case management, and other services specific to patients with rare and/or chronic diseases.

胜利者

好好学习

xqliu

谢谢提供分享