Your firm manufactures the over-the-counter (OTC) drug products “Age Blocker” and “Estro-Lift Day Therapy.”“Age Blocker” and “Estro-Lift Day Therapy” are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). “Age Blocker” is further misbranded under section 5...
21 U.S.C. 352(c). “Age Blocker” is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Introduction or delivery for introduction
Cathy Kelly
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 It was current when produced, but is no longer maintained and may be outdated.
Your firm manufactures the over-the-counter (OTC) drug products “Age Blocker” and “Estro-Lift Day Therapy.” “Age Blocker” and “Estro-Lift Day Therapy” are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). “Age Blocker” is further misbranded under section...
APPENDIX:CASESTUDYEXAMPLESOFMICROBIOLOGICALCONTAMINATIONOFNSDPRODUCTS;IMPACTONPRODUCTQUALITYANDMANUFACTURINGPROCESS 附录:案例研究:NSD产品的微生物污染示例;对产品质量和生产工艺的影响 MicrobiologicalQualityConsiderationsinNon-sterileDrugManufacturingGuida...
9 For purposes of this guidance, the term quality unit is synonymous with the term quality control unit. For the definition of quality control unit, see § 210.3(b)(15). 9 在本指南中, "质量部门" 一词是 "质量控制部门" 一词的同义词。有关质量控制部门的定义, 请参见§ 210.3(b)(15)。
The guidance describes proper prevention of andtesting for BCC in aqueous dosage forms of NSDs. 为了说明微生物风险评估和控制策略的重要性,本指南讨论了洋葱伯克霍尔德菌复合体(BCC)事件和其它非无菌制剂的微生物污染导致不良事件和产品召回的情况。本指南阐述了 NSD水性制剂中 BCC的恰当预防和检测。 The ...
The test of (b)(4) did not include any definition of a time element in the test method or results. It cannot be determined the duration of the test, or how often data readings were taken. 在企业21年11月12日的回复中,企业提供了两份测试报告,“压缩机温度测试协议和报告”和“xx测试协议...
o Detailed definition of the specific attributes to be tested at each station (timepoint). o详细定义在每个点(时间点)检验的具体属性。 • All procedures that describe these and other elements of your remediated stability program. • 描述整改稳定性计划的以上和其他要素的所有规程。 • A detailed...