FDA警告信

「

FDA

警告信」这是美国本土

API

生产商的

GMP

水

平？

April 7, 2016

WARNING LETTER NO.2016-NOL-02

UNITED PARCEL SERVICE

Delivery Signature Requested

Chris Lemley, President & CEO

Apotheca Supply, Inc. dba Apothecares

3220 Highway 31 South

Building B

Decatur, Alabama 35603-1731

Dear Mr. Lemley:

The U.S. Food and Drug Administration (FDA) inspected your pharmaceutical

manufacturing (repackaging and relabeling) facility, Apotheca Supply, Inc. dba

Apothecares, at 3220 Highway 31 South, Building B, Decatur, Alabama, from February

10-12, 2015.

We identified significant deviations from current good manufacturing practice (CGMP) for

the manufacture of active pharmaceutical ingredients (API).

These deviations cause your drugs to be adulterated within the meaning of Section 501(a)

(2)(B) of the Federal Food, Drug, and Cosmetic Act(the Act), 21 United State Code (USC)

351(a)(2)(B), because the methods used in, or the facilities or controls used for, their

manufacture, processing, packing, or holding do not conform to, or are not operated or

administered in conformity with CGMP.

We reviewed your February 23, 2015, response in detail; and, note it lacks sufficient

corrective actions. We also acknowledge receipt of your subsequent correspondence.

Our investigator observed specific deviations during the inspection,

including, but not limited to, the following:

调查员在检查时发现的特定的偏差

,

包括但不限于

:

quality unit failedto review and approve all quality related documents; and,

the mainresponsibilities of your quality unit were not described in writing.

你的质量部门 未能审核和批准所有质量相关文件

;

质量部门的主要职责没有书 面描述

.

During our inspection, we found your quality unit did not approve your written standard

operating procedures (SOPs) for numerous critical processes, such as quality unit

responsibilities, expiration date extension, material quarantine, product distribution,

equipment cleaning, product return, complaint handling, product recalls, supplier

qualification, raw material testing, and annual product reviews. We also found your

quality unit did not review and approve quality-related documents, batch records,

certificates of analysis, and the extension of API expiration dates. Specific examples

include:

在检查中

,

我们发现你们的质量部门不批准一些关键程序的

SOP,

例如质量部门职责

,

失效日

期延长

,

物料隔离

,

产品物流分布

,

设备清洁

,

产品返回

,

投诉处理

,

产品召回

,

供应商授权

,

原

料检验

,

和产品质量年度回顾

.

我们也发现你们质量部门不审核和批准与质量相关的文件

,

批记录

, COA

和延长后的