首页 > 资讯 > 【识林翻译】近期中文版警告信：基于关键词的索引

出自识林

2024-12-14

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TJA Health, LLC

FDA | 2024-07-17

关键词：【二甘醇/乙二醇】【制药用水】【洋葱伯克霍尔德菌群】

部分原文：

1.Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

未能对每一原辅料样品进行鉴别检验，以确定符合适当的纯度、规格和质量的书面标准（21 CFR 211.84(d)(1)和211.84(d)(2)）。

2.Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

2.未能建立能胜任的质量控制部门，使其具备职权来批准或拒绝所有原辅料、药品容器、密闭件、中间体、包材、标签及成品（21 CFR 211.22(a)）。

CARsgen Therapeutics Corporation

FDA | 2024-07-26

关键词：【CAR-T】【虫害】【非活性微粒监测】【消毒】【OOS】

部分原文：

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin. Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner. [21 CFR 211.56(a)]. Specifically, on July 14, 2023, your Quality Assurance team observed a box of food from June 16, 2023, covered in scuttle fly pupae in the mechanical room which houses the air handling units and failed to remove the box of food until July 31, 2023. After this event, scuttle fly larvae were found in ten environmental and personnel monitoring samples collected in the cleanrooms in July 2023. Additionally, on July 26, 2023, in Suite (b)(4) Clean Room (b)(4) (Grade (b)(4)) a living scuttle fly was observed on the tube rack. Adequate control of insect infestation is needed to ensure product quality and safety.

未能维护药品生产、加工、包装和贮存所用厂房的清洁卫生，保持其不受鼠类、鸟虫以及其它害虫的侵扰。应及时以卫生地方式存放和处置垃圾和有机废物。[21 CFR 211.56(a)]。具体而言，2023年7月14日，企业质量保证团队在空气处理机组所在的机房发现一盒2023年6月16日生产的食物，上面长满了蚤蝇蛹，直到2023年7月31日才移开食物盒。此事件后，2023年7月在洁净室采集的10份环境和人员监测样本中发现了蚤蝇幼虫。此外，2023年7月26日，在XX车间XX洁净室（XX级）的管架上观察到一只活蚤蝇。需要充分控制昆虫侵扰，以确保产品质量和安全性。

Eugia Pharma Specialities Limited

FDA | 2024-08-15

关键词：【无菌制剂】【完整性测试】【批记录】【微生物污染】【无菌验证】【偏差调查】【数据可靠性】

部分原文：

1.Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

1.未能确保实验室记录包括所有必要检验的完整数据，以确保符合既定质量标准（21 CFR 211.194(a)）。

2.Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

2.未能编制批生产与控制记录，其中包括与所生产的每批药品的生产和控制有关的完整信息（21 CFR 211.188）。

Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta

FDA | 2024-08-20

关键词：【BIMO】【临床方案偏离】

部分原文：

You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

未能确保按照研究计划进行研究[21 CFR 312.60]。

As a clinical investigator, you are required to ensure that your clinical studies are conducted in accordance with the investigational plan. The investigational plan for Protocol (b)(4) required the investigational drug (b)(4) to be administered to subjects according to their weight and in accordance with the protocol's titration schedule for the 20-week Titration Phase. During the 20-week Titration Phase, the protocol required a daily dose of (b)(4), with the dose of (b)(4) to increase according to the titration schedule at each study visit, which occurred every two weeks. According to the protocol's titration schedule, subjects at Visit 2 who were 12 to <18 years old were to receive an (b)(4) of (b)(4) at a daily dose of 0.2 mg/kg, not to exceed 12.5 mg per day.

作为临床研究者，企业必须确保按照研究计划进行临床研究。方案XX的研究计划要求研究用药品XX根据受试者的体重并按照方案中20周滴定期的20周滴定时间表给药。在20周滴定期，方案要求每天给予XX的剂量，根据滴定时间表在每次研究访视时增加XX的剂量，每两周进行一次。根据方案的滴定时间表，在第2次访视时，年龄在12岁至<18岁的受试者每天接受XX或XX的剂量为0.2 mg/kg，不超过12.5 mg/天。

Zydus Lifesciences Limited

FDA | 2024-08-29

关键词：【无菌制剂】【交叉污染】【清洁】【玻璃微粒】【微生物污染】【PPQ统计】

部分原文：

1.Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

1.未能彻底调查任何不明原因的差异或任一批次的失败或原辅料不符合其任一质量标准，不管该批次是否已经放行销售（21 CFR 211.192）。

2.Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

2.未能制订并遵守适当的书面规程，用以防止理应无菌的药品受到微生物污染，包括所有无菌工艺和灭菌工艺的验证（21 CFR 211.113(b)）。

3.Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100 (a) and 211.100 (b).

3.未能制订并遵守适当的生产和工艺控制书面规程，以确保所生产药品具备其所声称或表明拥有的鉴别、规格、质量和纯度（21 CFR 211.100 (a)和211.100 (b)）。

MMC Healthcare Ltd.

FDA | 2024-09-24

关键词：【倒填记录】【计算机授权】【方法学验证】【数据可靠性】

部分原文：

1.Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

未能建立能胜任的质量管理部门，并具有批准或拒绝所有原辅料、药品容器、密封件、中间体、包装材料、标签及药品的职责与权力（21 CFR 211.22(a)）。

2.Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

2.未能对计算机或相关系统采取适当控制，以确保生产及控制主记录或其他记录仅能由授权人员进行变更（21 CFR 211.68(b)）。

3.Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

3.未能确定其检验方法的准确度、灵敏度、专属性和重现性（21 CFR 211.165(e)）。

Supercore Products Group, Inc.

FDA | 2024-09-26

关键词：【膳食补充剂】【添加活性物质】【错标】

部分原文：

Information on the label and labeling of your "Hard Steel" and "Gold Hard Steel Plus" products demonstrate that these products are marketed as dietary supplements. However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Viagra (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. Given that sildenafil was not marketed as a dietary supplement or as food before Viagra was approved, your "Hard Steel" and "Gold Hard Steel Plus" products are excluded from the definition of dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).

“Hard Steel”和“Gold Hard Steel Plus”产品标签和说明书上的信息表明，这些产品作为膳食补充剂上市销售。但是，根据FD＆C法案第201(ff)(3)(B)(i)节[21 U.S.C. 321(ff)(3)(B)(i)]，膳食补充剂不得包括根据FD＆C法案第505节被批准为新药的物品，除非该物品被批准为药物之前作为膳食补充剂或食品上市销售。FDA于1998年3月27日批准万艾可（含有西地那非作为活性成分）为新药。鉴于西地那非在万艾可获批之前并未作为膳食补充剂或食品上市销售，企业的“Hard Steel”和“Gold Hard Steel Plus”产品不符合FD＆C法案第201(ff)(3)(B)(i)节[21 U.S.C. 321(ff)(3)(B)(i)]节的膳食补充剂定义。

Louisiana State University Health Science Center IRB

FDA | 2024-09-27

关键词：【BIMO】【IRB】

部分原文：

1.The IRB failed to conduct continuing review of research at intervals of not less than once per year [21 CFR 56.109(f)]

1.IRB未能按照至少每年一次的间隔对研究进行持续审查[21 CFR 56.109(f)]。

2.The IRB failed to prepare, maintain, and follow required written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and [the] Food and Drug Administration (FDA) [21 CFR 56.115(a)(6) and 56.108(b)(3)].

2.IRB未能编制、维护和遵守所要求的书面规程，以确保及时向IRB、适当的机构官员和FDA报告[21 CFR 56.115(a)(6)和56.108(b)(3)]。

Analytical Food Laboratories, Inc.

FDA | 2024-10-10

关键词：【QC实验室】【方法学验证】【系统适用性】【培养基】【委托检验】

部分原文：

1.Your firm failed to establish and follow required laboratory control mechanisms, and to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(a) and 211.160(b)).

1.未能制定并遵循所需的实验室控制机制，也未能制定包括科学上合理且适当的质量标准、标准、取样方案和检验程序的实验室控制规程，以确保原辅料、药品容器、密封件、中间体、标签和药品符合适当的鉴别、规格、质量和纯度标准（21 CFR 211.160(a)和211.160(b)）。

2.Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

2.质量控制部门未履行其职责确保所生产的药品CGMP合规，并且符合鉴别、规格、质量和纯度的既定标准(21 CFR 211.22)。

Armstrong County Memorial Hospital

FDA | 2024-10-29

关键词：【BIMO】【IRB】

部分原文：

1.The IRB failed to prepare, maintain, and follow written procedures governing the functions and operations of the IRB [21 CFR 56.108(a) and (b); 21 CFR 56.115(a)(6)].

1.IRB未能编制、维护并遵循管理IRB职能和运作的书面规程[21 CFR 56.108(a)和(b)；21 CFR 56.115(a)(6)]。

2.The IRB failed to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings [21 CFR 56.115(a)(2)].

2.IRB未能编制并维护充分的IRB活动文件记录，包括IRB会议记录[21 CFR 56.115(a)(2)]。

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