你公司的执行管理层仍然负责解决所有缺陷和系统性缺陷,以确保持续符合CGMP。 结论 The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of these violations and for pre...
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence or the occurrence of other violations. 本信函中引用的...
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. 您的质量部门未能履行职责,来确保在您的工厂生产的API符合CGMP。 Your facility repacks and relabels API. Your QU failed to perform adequate functions to ensure that...
你公司的执行管理层仍然负责解决所有缺陷和系统性缺陷,以确保持续符合CGMP。 Drug Registration Violation 违反药品注册(略) 结论 The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining...
和清洁验证不符合cGMP,QU职责不合适,FDA发出警告信。 WARNING LETTER Clinical Resolution Laboratory Inc. MARCS-CMS 615236 — MARCH 01, 2022 March 1, 2022 Dear Mr. Lee: The U.S. Food and Drug Administration inspected your drug manufacturing facility, Clinical Resolution Laboratory Inc., FEI 300572724...
质量控制部门未能履行其职责,确保生产的药品符合CGMP的要求。 1.1.Quality Assurance (QA) and production departments failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at the facility. Visual inspectors manipulated particle and...
你聘用顾问并不能免除公司遵守CGMP的义务。你公司的执行管理层仍然负责解决所有缺陷和系统性缺陷,以确保持续符合CGMP。 Drug Registration Violation 违反药品注册(略) 结论 The violations cited in this letter are not intended to be an all-inclusive list of violations th...
你聘用顾问并不能免除公司遵守CGMP的义务。你公司的执行管理层仍然负责解决所有缺陷和系统性缺陷,以确保持续符合CGMP。 暂停药品生产 Drug Production Suspended We acknowledge your commitment to suspend manufacture of drugs at the (b)(4) facility. In response to this letter, clarify whether you intend to ...
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence or the occurrence ...
Your firm failed to implement adequate controls to ensure the integrity of data generated at your facility. Your firm is a contract testing laboratory that performs CGMP testing of crude heparin and active pharmaceutical ingredient (API) heparin sodium, USP. Testing performed by your firm, among ot...