WARNING LETTERCMS 535005December 19, 2017VIA UPS NEXT DAY AIRPaul F. Devine, CEOPresidentC.O. Truxton, Inc.136 Harding A
Broadly, the label is a compilation of information about the product which, while written by the manufacturer, must be approved by FDA. The label is, of course, based on the information submitted to FDA in the new drug application, biological license application or other relevant application. ...
《美国联邦法规》按照法律规范所涉及的领域和调整对象,分为50个主题Title,其中Title 21-Food and Drugs 第21个主题是食物和药品,Part 201 - LABELING 第201部分是药品标签,Section 201.1 - Drugs; name and place of business of manufacturer, packer, or distributor. 第201部分下面第一节是药品生产商,包装商或...
15.APPENDIXG:DAILYVALUESFORINFANTS,CHILDRENLESS THAN4YEARSOFAGE,ANDPREGNANTANDLACTATINGWOMEN128 16.APPENDIXH:ROUNDINGTHEVALUESACCORDINGTOTHE FDAROUNDINGRULES129 ContainsNonbinding Recommendations GuidanceforIndustry AFoodLabelingGuide Thisguidancerepresentsthe ...
美国FDA药品标签法规要求 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
(4)FDCA第609节:化妆品标签和香精过敏原披露(Cosmetic Labeling and FragranceAllergen Transparency) MoCRA颁布之前,产品标签只需要标注“Fragrance”即可,未强制标注香精过敏原相关信息。但新增的第609节,在FDA化妆品标签当前要求的基础上,设定了三种方式:
1. Inresponse to our observation that microbial contamination was present within theISO 5, you stated that you use (b)(4) witha contact time of (b)(4) toinactivate spore-forming Bacillus. However, the manufacturer’s labelingrecommends a (b)(4) contacttime for sporicidal activity. Your ...
801.1 Medical devices; name and place of business of manufacturer, packer or distributor.第 801.1 节医疗器械;制造商、包装商或分销商的名称和营业地点。(a) The label of a device in package form sha... 文档格式:PDF | 页数:66 | 浏览次数:848 | 上传日期:2022-09-21 19:29:43 | 文档星级:...
In your response, you stated that you have discontinued using heat-sealed pouches that are clear on one side and will test your replacement container-closure systems to demonstrate that they meet manufacturer recommendations for light protection. ...
Specifically, an HCT/P meets the criterion established by 21 CFR 1271.10(a)(2) if it is “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent.”3As noted above, your products are intended to treat a variety...