翻译：JULIA 来源：
Julia法规翻译
ViaUPS
Warning Letter
320-17-42
July 28, 2017
Mr. Juan Pablo Bertotto
Chief Operating Officer
Skin Sciences Laboratory, Inc.
Unit 101 Central Business Park, Amang RodriguezAvenue, Manggahan
Pasig City, 1611 Philippines
Dear Mr. Bertotto:
The U.S. Food and Drug Administration (FDA) inspectedyour drug manufacturing facility, Skin Sciences Laboratory Inc. at Unit 101Central Business Park, Amang Rodriguez Avenue, Manggahan Pasig City, fromJanuary 30 to February 1, 2017.
美国
FDA
于
2017
年
1
月
30
日至
2
月
1
日检查了你们位于菲律宾的
Skin Sciences
制剂生产场所。
This warning letter summarizes significant violationsof current good manufacturing practice (CGMP) regulations for finishedpharmaceuticals. See 21 CFR, parts 210 and 211.
本警告信总结了制剂生产严重违反
CGMP
的行为。参见
21CFR
，第
210
和
211
部分。
Because your methods, facilities, or controls formanufacturing, processing, packing, or holding do not conform to CGMP, yourdrug products are adulterated within the meaning of section 501(a)(2)(B) of theFederal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
由于你们的制剂生产、加工、包装或保存的方法、场所或控制不符合
CGMP
要求，你们的制剂根据
FDCA
的
501(a)(2)(B)
以及
21 U.S.C. 351(a)(2)(B)
被认为是掺假药品。
The inspection also revealed that your firmmanufactures and distributes unapproved new drugs in violation of section505(a) of the FD&C Act, 21 U.S.C. 355(a). Additionally, FDA has determinedthat one of the drug products you manufacture is misbranded in violation ofsection 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
检查还揭示出你们公司生产和销售了未经批准的新药，违反了
FDCA
第
505(a)
部分和
21 U.S.C. 355(a)
部分。另外，
FDA
已决定你们生产的药品之一为冒牌药，违反了
FDCA
第
502(f)(1)
部分和
21 U.S.C.352(f)(1)
部分。
We reviewed your February 16, 2017, response in detailand acknowledge receipt of your subsequent correspondence.
我们详细审核了你们公司
2017
年
2
月
16
日及之后的回复。
During our inspection, our investigator observedspecific violations including, but not limited to, the following.
检查期间，我们的调查人员发现的具体问题包括但不仅限于以下：
CGMP Violations
