首页 > 资讯 > 【警告信翻译】中国和印度 API，放行检验，委托生产，偏差 OOS 调查，交叉污染，二甘醇鉴别等

出自识林

2025-03-15

Jagsonpal Pharmaceuticals Limited

FDA | 2025-02-18

关键词：【印度】【API】【委托生产】

部分原文：

On March 15, 2024, the FDA arrived at the registered address, B-1124, RIICO Ind. Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, 301019, India, to conduct an inspection and was refused entry by individuals present at this address.

2024年3月15日，FDA到达注册地址（B-1124, RIICO Ind. Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, 301019, India）进行检查，但被该地址人员拒绝进入。

On March 20, 2024, the FDA was permitted to enter the facility at the registered address to conduct an inspection; however, access to requested documents was limited during the inspection. For example, complete analytical data, equipment logbooks, and change control documents were not provided upon request because, according to your representatives, the facility was in (b)(4) status. Representatives from Jagsonpal and your CMO were present during these requests.

2024年3月20日，FDA被允许进入注册地址的工厂进行检查；但在检查期间，很难获得所要求的文件。例如，未应要求提供完整的分析数据、设备日志和变更控制文件，因为据企业代表称，工厂处于XX状态。Jagsonpal和企业CMO的代表在提出这些要求时在场。

Chengdu Innovation Pharmaceutical Co., Ltd.

FDA | 2025-02-11

关键词：【中国】【API】【物料鉴别】【放行体系】

部分原文：

1. Failure to test the identity of each lot of incoming production material.

1. 未对每批入厂生产物料进行鉴别检验。

You manufacture APIs that were distributed to (b)(4) in the United States. Based on the records and information you provided, you have not demonstrated that you are adequately testing each shipment of each lot of incoming materials. Specifically in response to our request, you state that you do not perform identity testing on each shipment of each lot of incoming material before they are released for use in drug manufacturing.

企业生产分销至美国XX的API。根据企业提供的记录和信息，企业没有证明对入厂物料的每个发运批都进行了充分检验。具体而言，在对FDA要求的回复中，企业表示，在放行用于药品生产之前，没有对入厂物料的每个发运批进行鉴别检验。

Without adequate testing, you do not have scientific evidence that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality.

如果没有充分的检验，企业就没有科学证据证明入厂物料在用于药品生产之前符合适用的质量标准。作为生产商，企业有责任在入厂原料用于生产之前对其进行取样、检验和检查，以确保其质量合格。

AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp

FDA | 2025-01-29

关键词：【放行检验】【工艺性能确认】

部分原文：

1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

1. 每批药品放行前，未能进行适当的实验室检验，以判定与药品最终质量标准（包括每种活性成分的鉴别、规格）的完全符合性（21 CFR 211.165(a)）。

2. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm's quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

2. 未能制订生产和工艺控制书面规程，以保证药品所声称的或表明拥有的鉴别、规格、质量和纯度，且质量管理部门未能审核和批准这些操作规程，包括任何变更（21 CFR 211.100(a)）。

Granules India Limited

FDA | 2025-02-26

关键词：【严重污染】【微生物污染】【清洁】

部分原文：

1. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

1. 未能建立并遵循适当的书面规程来清洁和维护设备（21 CFR 211.67(b)）。

2. Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).

2. 未能保持用于药品生产、加工、包装或贮存的厂房处于良好的维修状态（21 CFR 211.58）。

3. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).

3. 未能根据对用于药品生产、加工、包装和贮存的自动、机械、电子设备或其它类型设备（包括计算机化系统）的书面规程对其进行例行校准、检查或核对，以保证此类设备工作性能良好（21 CFR 211.68(a)）。

Chem-Tech, Ltd.

FDA | 2025-02-11

关键词：【OOS】【原辅料】【污染】

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偏离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 clean, maintain, and sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b)).

2. 未能定期清洁、维护、消毒和/或灭菌设备和器具，防止出故障或污染，以免改变药品的安全性、成分、规格、质量或纯度而超出官方或其它既定要求，也未能制订并遵守适当的设备清洁和维护书面规程（21 CFR 211.67(a)和(b)）。

3. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).

3. 未能制订并遵守适用于质量管理部门的适当的书面职责和规程（21 CFR 211.22(d)）。

ABR Laboratory LLC

FDA | 2025-02-10

关键词：【合同检验实验室】【分析方法验证】【实验室环境】

部分原文：

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

1. 未能建立并记录检验方法的精确度、灵敏度、专属性和重现性（21 CFR 211.165(e)）。

2. 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).

2. 未能彻底调查任何不明原因的偏离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）。

Marshalls Traditional Healthcare CC

FDA | 2025-02-10

关键词：【放行检验】【工艺验证】

部分原文：

1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

1. 每批药品放行前，未能进行适当的实验室检验，以判定与药品最终质量标准（包括每一活性成分的鉴别、规格）的完全符合性。也未能对要求不含有害微生物的每批药品进行适当的实验室检验（21 CFR 211.165(a)和211.165(b)）。

2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the 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)).

2. 未能制定并遵守旨在确保所生产的药品具备其声称或表明拥有的鉴别、规格、质量和纯度的充分书面生产和工艺控制规程（21 CFR 211.100(a)和211.100(b)）。

Tyche Industries Ltd

FDA | 2025-02-06

关键词：【记录】【数据可靠性】

部分原文：

1. Failure to record all quality-related activities at the time they are performed.

1. 未能在执行时记录所有质量相关活动。

2. Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications.

2. 未能清洁设备和器具，以防止会改变原料药质量的污染或物料残留超出官方或其它既定质量标准。

3. Failure to test the identity of each batch of incoming production material.

3. 未能对每批入厂生产物料进行鉴别检验。

Strukmyer LLC dba Strukmyer Medical

FDA | 2025-01-30

关键词：【水系统】【偏差调查】【二甘醇/乙二醇鉴别】

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偏离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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

2. 未能对每一原辅料样品进行鉴别检验并确定是否符合纯度、规格和质量的所有适用书面质量标准。也未能定期验证并建立对原辅料供应商检验分析的信任关系（21 CFR 211.84(d)(1)和211.84(d)(2)）。

3. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

3. 未能定期清洁、维护设备和器具，并根据药品性质进行消毒和/或灭菌，防止出故障或污染，以免改变药品的安全性、鉴别、规格、质量或纯度超出官方要求或其他既定要求（21 CFR 211.67(a)）。

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