FDA警告信：澳大利亚Tismor Health and Wellness Pty Limited 20191205

Warning Letter  320-20-10
December 5, 2019
 
Dear Mr. Siracusa:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tismor Health and Wellness Pty Limited, FEI 3008932054, at 19a Garema Cct, Kingsgrove, from May 20 to 24,2019.
美国FDA于2019年5月20日至24日检查了你们位于澳大利亚的Tismor Healthand Wellness Pty Limited（FEI3008932054）生产场所。
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
本警告信总结了制剂生产严重违反CGMP的行为。参见21CFR第210与211部分。
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
由于你们的制剂生产、加工、包装或保存的方法、场所或控制不符合CGMP要求，你们的药品根据FDCA的501(a)(2)(B)以及21 U.S.C. 351(a)(2)(B)被认为是掺假药品。
Your firm manufactures “Thursday Plantation Tea Tree Antiseptic Cream." This product is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21U.S.C. 331(d). These violations are described in more detail below.
你公司生产“周四种植园茶树抗菌乳膏”违反FDCA第505(a)条款21 U.S.C. 355(a)，为未经批准的新药。FDCA第301(d)条款21 U.S.C. 331(d)禁止将此类药品引入或输入州际贸易。以下对此违规情况进行了详细说明。
We reviewed your June 14, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
我们已详细审核了你公司2019年6月14日对FDA483表的回复，并此告知已收到后续通信。
During our inspection, our investigator observed specific violations including, but not limited to, the following.
检查期间，我们的调查人员发现的具体问题包括但不仅限于以下：
CGMP Violations CGMP违规
1.   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). 你公司未对计算机和相关系统进行适当控制，确保仅有经过授权的人员方可修改主生产和检验记录和其它记录（21 CFR 211.68(b)）。
Your firm contract manufactures over-the-counter (OTC) topical drug products(b)(4). Your firm lacked sufficient controls over your gas chromatography (GC) instrument used to test the drug productprior to release. Specifically, your firm assigned administrative privileges to analysts conducting routine assay tests using your Empower chromatography software data system.
你公司委外生产OTC局部药品XX。你公司对你们的药品放行检测用GC仪器缺乏足够控制。具体来说，你公司将管理员权限授予日常使用EMPOWER色谱软件数据系统执行含量检测的化验员。
During the review of your Empower chromatography audit trail for your drug product, our investigator observed that you deleted more than 100 test results since October 2017. You also aborted more than 100 sample set results during this same period, although you lacked investigations.
在对你们药品的EMPOWER色谱审计追踪进行审核时，我们检查员发现你们自2017年10月以来删除了100多个检测结果。你们在相同时间段还中断了100多个样品序列结果，但并未进行调查。
Your quality system does not adequately ensure the accuracy and integrity of the data to support the safety, effectiveness and quality of the drugs you manufacture. Without complete and accurate records,you cannot assure appropriate decisions regarding batch release, product stability, and other matters that are fundamental to ongoing assurance of quality.
你们的质量体系不能充分保证支持你们所生产的药品的安全性、有效性和质量的数据的准确性和完整性。没有完整准确的记录，你们无法确保做出适当的批放行、产品稳定性和其它持续保证质量的基本事务决策。
Your response acknowledged that analysts did not understand the implications of deleting data and attributed the problem to the lack of data integrity training at your firm. You also stated there was nor equirement in your standard operating procedures (SOPs) to regularly review audit trails.
你们在回复中承认化验员并不理解删除数据的意义，将问题归结于你公司缺乏数据完整性培训。你们还声称在你们的SOP中不要求对审计追踪进行定期审核。
You stated that procedural updates will include guidance on management of users, assignment of administrative privileges, and the circumstances when administrative privileges can be used. However, your updated procedures still allow analysts to perform “trial work,” which your firm intended to maintain in a separate folder from routine analysis. This is an unacceptable practice. It is essential that all data from the analysis of drug samples be retained and reviewed.
你们声称对程序的更新会包括用户管理指导、管理者权限授权，以及管理者权限可以使用的情景。但是你们更新后的程序仍允许化验员进行“试验性工作”，你公司准备将这部分内容保存在一个与日常分析不同的单独文件夹。这是不可接受的。保存和审核药品样品分析所得所有数据是基本要求。
You committed to investigate previously deleted data and aborted sample sets. Your firm also indicated it will take further actions depending on the outcome of this investigation. Your response is inadequate. You did not assess GC data related to all batches of products distributed to the U.S. to ensure there was no impact to quality or commit to a larger review of all data generated in your laboratory. Your response lacks an independent review including, but not limited to, an evaluation of the origin of behaviors and decisions that led to deletion of quality control data. Your response did not provide adequate detail of your full scope of improvements and management oversight to prevent future data integrity issues.
你们承诺会调查之前删除的数据和中断的样品序列。你们公司亦指出根据该调查的结果可能会采取更多措施。你们的回复是不充分的。你们并未评估与所有销售至美国的批次有关的GC数据，以确保对质量没有影响，或承诺更多审核你们实验室产生的所有数据。你们的回复缺乏独立审核，包括但不仅限于评估导致质量检测数据删除的行为和决策来源。你们的回复并未提交足够的详细的全范围改进和管理监管，以防止未来发生数据完整性问题。
In response to this letter, provide the following:
在回复本函时请提交以下：
A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
一份对你们实验室规范、程序、方法、设备、文件和化验员能力的全面独立评估。基于该项审核，提交一份对你们的实验室系统的详细补救计划并对其有效性进行评估。
A comprehensive assessment and remediation plan to ensure your quality unit (QU) is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
一份全面的评估和补救计划，确保你们的QU被授予权力和资源可有效运作。评估还应包括但不仅限于：
A determination of whether procedures used by your firm are robust and appropriate
确定你公司所用程序是否稳健恰当
Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
QU监管你们整体运营以评估是否遵守适当规范的条款
A complete and final review of each batch and its related information before the QU disposition decision
在QU做出处置决策之前对每批及其相关信息进行完整最终审核
Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
监管和批准调查，履行所有其它QU义务，确保所有产品的鉴别、含量、质量和纯度
Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
还请描述高级管理层如何支持质量保证和可靠运营，包括但不仅限于及时提供资源积极处理新发生的生产/质量问题，确保持续受控
A comprehensive, independent assessment of computer system performance and security. Provide a report that identifies vulnerabilities in the design and controls, and a thorough corrective action and preventive action (CAPA) plan for each of your laboratory computer systems, which addresses the following elements.
一份对计算机系统性能和安保的全面独立评估。提交一份报告识别出设计和控制方面的薄弱点，以及一份对你们实验室所有计算机系统的全面CAPA计划，其中应包括以下要素：
A list of all hardware (both standalone and networked) and software used by your laboratory.
一份你们实验室使用的所有硬件（单机和网络）和软件的清单
Identify and evaluate vulnerabilities in performance and security of all of these computer systems, including but not limited to their configurations, administrative rights, password controls, audit trails capabilities and state of implementation for each system, qualification/validation status, deviation history, backup capabilities, network requirements, completeness of data records, suitability of current hardware/software for its intended use(s), change management, and management oversight.
识别和评估所有这些计算机系统的性能和安保薄弱点，包括但不仅限于其参数设置、管理权限、密码控制、审计追踪能力和每个系统的执行状态、确认/验证状态、偏差历史、备份能力、网络要求、数据记录的完整性、当前硬件/软件是否适合其既定用途、变更管理和管理监管
Detail the associated user privileges for each system.
每个系统的详细用户权限
Specify user roles and associated user privileges for all staff levels who have access to the laboratory computer system, and provide organizational affiliations, responsibilities, and titles. Clearly specify all staff who have administrator privileges.
为所有可访问实验室计算机系统的员工层次写明用户角色和相关用户权力，提交一份组织隶属关系、职责以及职务
Fully describe how you will ensure segregation of firm personnel involved with laboratory testing from those with administrator rights. For all staff roles that are permitted to have administrative rights, specify the scope and type of privileges.
全面说明你们要如何确保将公司涉及实验室检测的人员与管理员权力分开。说明所有具备管理员权限的员工角色的权力范围与类型
Assess each system to determine if unique user names and passwords are used.
评估每个系统是否使用了唯一用户名和密码
Evaluate policies and procedures regarding computers and data governance, with special emphasis on audit trails, prohibiting data deletion, and appropriate modifications of results. Specify how your firm prevents data deletion and undocumented/inappropriate modifications of data. Also describe how you ensure original data and information is always preserved. Provide your procedures for audit trail review.
评估计算机和数据管理政策与程序，特别要注意审计追踪、禁止数据删除以及对结果的恰当修改。说明你公司要如何防止数据删除和没有文件记录的/不当数据修改。亦请说明你们要如何确保一直会保存原始数据和信息。提交你们的审计追踪审核程序。
Provide requirements for data retention and backup for all laboratory systems.
提交所有实验室系统数据保存和备份要求。
Describe how you ensure that all quality control tests are performed by an analyst and receive second-tier review from a separate qualified individual (e.g., lab manager). Provide related procedure(s).
说明你们要如何确保所有QC检测由化验员执行，并由单独指定人员（例如实验室经理）进行第二级审核。提交相关程序。
Summarize your interim controls to assure reliable performance and security while your CAPA plan is being implemented.
总结你们的临时控制措施，确保你们的CAPA计划执行时的可靠表现和安全性。
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 (21 CFR 211.100(a)). 你公司未制订书面生产和检测控制，以控制你们生产的药品具备其理当具备或显示具备的鉴别、含量、质量和纯度（21 CFR 211.100(a)）。
Your firm has not qualified the equipment, such as (b)(4), used to manufacture your drug product. In addition, you did not record the (b)(4)of the (b)(4) used at various steps during production in the batch record.
你公司未对药品生产用设备进行确认，例如XX。另外，你们并未在生产期间各步骤中在批记录里记录所用XX。
The batch record for the drug product required (b)(4) of components at (b)(4) for(b)(4), but your (b)(4) did not have graduated (b)(4) values, nor does it assure a known (b)(4).Instead, the (b)(4) range from (b)(4), with (b)(4) corresponding to a claimed maximum (b)(4) of (b)(4).
药品批记录要求在XX时加入组份XX，但你们的XX并没有刻度XX值，亦不能确保已知XX。相反，XX范围为XX，其对应所声明的最大XX。
In your response, you stated that you will qualify the (b)(4) tank and (b)(4) to demonstrate that the equipment is suitable for its intended use. Specifically, you plan to qualify the (b)(4) to ensure that the operators can set the (b)(4) for the(b)(4) tanks accurately. You qualified the (b)(4) value by using previous process validation work, in which the (b)(4) was set at (b)(4) and was expected to represent a (b)(4) of approximately (b)(4).
在你们的回复中，你们声称你们会确认XX罐和XX，证明设备适合其既定用途。具体来说，你们计划确认XX以确保操作员可准确设置XX罐。你们使用之前的工艺验证工作确认的XX值，该工艺验证中XX被设置为XX，代表的是约XX。
In your response you stated you have determined speeds at different dial settings and will perform qualification studies to ensure the equipment is suitable for its intended use. Your response is inadequate. Your firm did not assess the potential impact on quality (e.g., (b)(4))if the (b)(4) does not function at the (b)(4) defined during process validation. There is no assurance that previously distributed batches were manufactured with qualified equipment suitable for its intended use.
在你们的回复中，你们声称你们已确定了不同按键设置的速度，并会进行确认研究以确认设备适合其既定用途。你们的回复是不充分的。你公司并未评估如果XX在工艺验证中未能在指定的XX正确动作对质量（例如XX）会产生什么潜在影响，因此无法确保之前销售的批次是采用经确认适合其既定用途的设备生产的。
In response to this letter, provide the following:
在回复本函时请提交以下：
A data driven, scientifically sound qualification program that identifies and controls variability, such that your production and packaging processes meet appropriate manufacturing standards and parameters. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, and determining the capability and reliability of each manufacturing     process step and control.
一份依据数据的科学合理确认程序，识别和控制波动情况，使得你们的生产和包装工艺符合适当的生产标准和参数。其中包括但不仅限于评估设备是否适合其既定用途，确保输入原料的质量，以及确定每个生产工艺步骤和控制的能力和可靠性
An assessment of distributed batches of your drug product. Provide your plans for addressing any product quality risks identified for any drug products still in distribution, including notifications or market actions.
一份对你们药品已销售批次的评估。提交你们解决所有已识别仍在销售中的药品质量风险的计划，包括通知客户和市场召回措施。
3.   Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug products conform to appropriate standards ofidentity, strength, quality, and purity (21 CFR 211.160(b)). 你公司未制订实验室控制系统，包括科学合理和恰当的质量标准、取样计划和检测程序，用于确保组份和药品符合适当的鉴别、含量、质量和含量标准（21 CFR 211.160(b)）。
Your firm failed to validate the Excel spreadsheet used to perform the assay calculation for your “(b)(4).” Your procedures lacked guidance on how to check and manually verify the calculation sheets.During the inspection, our investigator identified a calculation error within the spreadsheet. The incorrect formula for averaging the Internal Standard peak area was used.
你公司未对你们“XX”含量计算所用的EXCEL表格进行验证。你们的程序缺少了如何检查和手动验算表的指南。在检查中，我们检查员发现表格内有计算错误。计算内标峰面积平均值的公式是错误的。
There is no assurance that the associated assay results recorded are reliable and accurate.
这样无法保证所记录的相关含量结果是准确可靠的。
In your response, you stated that you have retrospectively tested products in the market using correct procedures and will update the validation master plan to ensure that spreadsheets are included within the scope of validation efforts. You created a new procedure which details the approach for validating spreadsheets as well as protecting the file from accidental changes. You also stated all Excel spreadsheet calculations for your (b)(4) batches have been retrospectively reviewed.
在你们的回复中，你们声称你们已回顾性检测了采用错误程序计算的已销售产品，并会更新验证主计划以确保验证工作范围包括表格的验证。你们创建了新的程序，在其中详细说明了验证表格的方法，以及保护文件不受意外修改的方法。你们还声称你们的XX批次所有EXCEL表格计算均已进行了回顾审核。
During the review, you identified another error within your Excel spreadsheets. The assay test result for (b)(4) batch (b)(4) was incorrect due to a transcription entry error for active peak area. Your firm used a new spreadsheet and entered the correct active peak area. The result was recalculated, and the final result was reported. The product had already been released with test results using the incorrect calculation, although the recalculated test result was still within specification. You have committed to manually check calculations until the spreadsheet has been validated.
在审核期间，你们发现你们EXCEL表格中的另一个错误。XX批次的含量检测结果因为转抄录入主峰面积错误导致结果错误。你公司使用了新的表格，录入了正确的主峰面积，重新计算了结果，并且报告了最终的结果。虽然重新计算结果仍在标准范围内，但该产品已采用不正确的计算结果被放行。你们承诺会在完成表格验证之前对计算进行人工检查。
Your firm relied on Excel spreadsheets to calculate assay and determine the reportable result for final batch release. Your computerized systems must perform their functions satisfactorily and that your firm establish a written program to ensure ongoing proper system performance.
你公司依赖EXCEL表格计算含量并确定最终批放行的报告结果。你们的计算机化系统必须正确运行函数，你公司应建立书面程序确保系统功能持续正确。
Your response is inadequate. You have not fully assessed the potential impact of using data from unvalidated, unsecured spreadsheets for critical CGMP functions.
你们的回复是不充分的。你们并未全面评估使用未经验证的数据和不安全的表格于关键CGMP功能的潜在影响。
In response to this letter, provide the following:
在回复本函时请提交以下内容：
A comprehensive review of your laboratory practices, procedures, methods, equipment, and analyst competencies. Based on this review, provide a detailed CAPA plan to remedy your laboratory system. Your plan should include the process you will use to evaluate the effectiveness of the implemented CAPA plan.
一份对你们实验室规范、程序、方法、设备和化验员能力的全面审核。基于此审核，提交一份详细的CAPA计划补救你们的实验室系统。你们的计算应包括你们准备用来评估所执行的CAPA计划有效性的流程
A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
一份对你们生产和实验室操作所用的文件体系的完整评估，以确定文件规范是否充分。要包括一份详细的CAPA计划，全面补救你们公司的文件规范，确保你们会保存可追溯、清晰、完整、原始、准确、整个操作过程中的同步记录。
Responsibilities as a Contractor 作为合同商的义务
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers.FDA regards contractors as extensions of the manufacturer.
药品生产必须符合CGMP要求。FDA了解许多药品生产商使用独立合同方如生产场所、检测实验室、包装商和贴标商。FDA将合同商作为生产商的外延部分来对待。
You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength,quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
作为合同场所，虽然你们与药品所有者订有协议，但你们仍对你们所生产的药品负有义务。你们应确保药品生产符合FDCA第501(a)(2)(B)条款对安全性、鉴别、剂量、质量和纯度的要求。参见FDA指南文件“药品合同生产安排：质量协议”。
Data Integrity Remediation 数据完整性补救措施
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices athttps://www.fda.gov/downloads/DRUGS/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf.
你们的质量体系不能充分确保数据的准确性和完整性，无法支持你们生产的药品的安全性、有效性和质量。参见FDA指南文件“数据完整性和药品GMP合格”指导建立和遵守CGMP合格数据完整性规范。
We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide the following:
我们知悉你们正聘用顾问对你们的操作进行审计并协助你们符合FDA要求。在回复此函时请提交以下信息：
A. A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
一份对数据记录和报告不准确性程度的全面调查。要包括一份对你们数据完整性问题的范围与根本原因的详细说明。
B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
你们药品质量中所发现的不合格情况的潜在影响的当前风险评估。你们的评估应包括由于受到数据完整性问题影响的药品放行导致的患者风险的分析，以及持续运营所具有的风险。
C. A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.
你们公司的管理策略，包括你们全球CAPA计划详细情况。详细的纠正措施计划应说明你们准备如何确保你公司生成的所有数据的可靠性和完整性，包括微生物和分析数据、生产记录以及提交给FDA的所有数据。

Products Containing Glycerin 含丙三醇的药品
Your (b)(4) drug product contains glycerin.The use of glycerin contaminated with diethylene glycol (DEG) has resulted invarious lethal poisoning incidents in humans worldwide.
你们的XX药品含有丙三醇。使用受二甘醇（DEG）污染的丙三醇已导致全球多次人类因毒致死事件。
See FDA’s guidance document Testing of Glycerinfor Diethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing glycerin at https://www.fda.gov/media/71029/download.
参见FDA指南“丙三醇中EG检测”，有助于你们满足CGMP要求前提下销售使用了丙三醇的药品，以及对DEG的检测和供应链完整性的建议。
In responseto this letter, provide the following:
在回复本函时请提交以下内容：
Results of tests for DEG and EG in retain samples of all glycerin batches used to manufacture your drug products.
用于生产你们药品的所有丙三醇批次的留样中DEG和EG的检测结果
A full risk assessment for drug products that contain glycerin and are within expiry in the U.S. market. Take prompt corrective actions and preventive actions and detail your future actions to ensure appropriate selection of your suppliers, ongoing scrutiny of their supply chain, and appropriate incoming batch controls.
一份在美国销售且仍在效期内的含丙三醇的药品的全面风险评估。采取快速CAPA，并详细说明你们未来确保你们适当选择供应商、持续仔细审核其它供应链、以及适当的进厂批次控制的措施。
Any drug marketed by your firm must conform with all applicable requirements of the FD&C Act, including those outlined in the Unapproved New Charges section below.
你公司销售的所有药品必须符合FDCA所有适用要求，包括以下未批准新药指控部分所列要求。
Unapproved New Drug Violation 未批准新药违规（略）

Conclusion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 preventing their recurrence or the occurrence of other violations.
此函中所引用的违规并不是全部。你们有责任对这些偏差进行调查，确定原因，防止其再次发生，防止你们设施内其它偏差的发生。
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer.
在贵公司未能完成所有偏差纠正并且由我们确认你们符合CGMP之前，FDA可能会搁置所有将你公司列为药品生产的新申报和增补申报的批准。
Failure to correct these violations may also result in the FDA refusing admission of articles manufactured at Tismor Health and Wellness Pty Limited at 19a Garema Cct, Kingsgrove, into the United Statesunder section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C.351(a)(2)(B).
未能纠正这些偏差可能还会导致FDA依据FDCA第801(a)(3)条和21 U.S.C. 381(a)(3)拒绝接受在上述地址生产的产品进入美国。
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
在收到此函后，请在15个工作日内回复至本办公室。在回复中说明自从检查后，你们做了哪些工作来纠正你们的偏差，防止其再次发生。如果不能在15个工作日内完成纠正措施，说明延迟的原因以及完成计划。
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
 
           W. DeVore Irick
Compliance Officer
           U.S. Food and Drug Administration
           White Oak Building 51, Room 4235
10903 New Hampshire Avenue
           Silver Spring, MD 20993
           USA
Please identify your response with FEI 3008932054.
 
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

       文章来源：允咨GMP制药技术

       本网站刊载的所有内容，包括文字、图片、音频、视频、软件等，如非标注为“原创”，则相关版权归原作者所有，如原作者不愿意在本网站刊登相关内容，请及时通知本站，我们将第一时间予以删除。

曜分享

分享精彩资讯