FDA公布对Silgan Unicep Packaging的警告信，指微生物OOS取平均值放行批次

2026年10月13日，FDA公布一则警告信。

检查对象：Silgan Dispensing Systems

检查日期：2026 年 3 月 26 日至 4 月 2 日

483回复提交时间：2026 年 4 月 22 日

FDA 警告信日期：2026 年 10 月 5 日

Violations were observed and documented during an inspection of your drug manufacturing facility, Silgan Unicep Packaging, LLC, Facility Establishment Identifier (FEI) 3011913386, at 4122 South Grove Road, Spokane, Washington, from March 26 to April 2, 2026. This inspection was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

2026年3月26日至4月2日，FDA对贵司药品生产企业Silgan Unicep Packaging, LLC（机构识别码FEI：3011913386，地址：华盛顿州斯波坎市南格罗夫路4122号）开展现场检查，发现并记录多项违规事项。本次检查依据FDA法定职权与公共卫生职责开展，旨在保护公众免受不安全、无效及劣质药品危害。

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

本警告信概述成品药品现行良好生产规范（CGMP）法规相关重大违规事项。参见《美国联邦法规》第21篇第210和211部分（21 CFR 第210、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).

由于贵公司在生产、加工、包装或存放环节所采用的方法、设施或控制措施不符合CGMP要求，根据《联邦食品、药品和化妆品法案》（FD&C法案）第501(a)(2)(B)条（《美国法典》第21编351(a)(2)(B)）定义，贵公司生产的药品属于掺假药品。

In addition, violations were identified and documented during a review of the product labeling, including the product website at the internet address (b)(4) website in July 2026. Based on our review, "(b)(4)" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

此外，2026年7月，FDA在审阅产品标签（含网址为(b)(4)的产品官网）过程中，发现并记录相关违规。经核查，"(b)(4)"属于《联邦食品、药品和化妆品法案》（FD&C法案）第505(a)条（《美国法典》21编355(a)）定义下的未经批准新药。下文将进一步说明，依据FD&C法案第301(d)条及第505(a)条（《美国法典》21编331(d)、355(a)），禁止将上述产品投放或安排投放跨州商业流通。

We reviewed your April 22, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

我们已详细审阅贵公司2026年4月22日针对FDA 483表提交的回复材料，并确认收到贵公司后续往来函件。

Violations of the Federal Food, Drug, and Cosmetic Act

违反《联邦食品、药品和化妆品法案》事项

The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.

以下为本次检查与审阅过程发现的违规事项。特此提醒，该清单并未穷尽贵生产场所存在的全部违规问题。

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. 无论批次是否已经上市分销，贵公司未能对批次或其组分出现的无法解释的偏差、不符合质量标准的结果开展全面调查（21 CFR 211.192）。

Your firm contract manufactures non-sterile over-the-counter (OTC) (b)(4) drug products, including those labeled for use in (b)(4). You failed to adequately investigate out-of-specification (OOS) microbiological testing results for components used to manufacture your drug products.

贵司受托生产非无菌非处方药(b)(4)，其中包含标注用于(b)(4)的产品。对于药品生产所用物料的微生物超标（OOS）结果，贵司未开展充分调查。

For example, in November 2025, you obtained OOS microbiological results for (b)(4) lots (b)(4). You prepared (b)(4) independent samples from each lot. You tested (b)(4) of the samples for total aerobic microbial count and the (b)(4) samples for total yeast and mold count. One sample from each lot exceeded your total yeast and mold count acceptance criterion of no more than (b)(4) colony forming units per gram.

举例：2025年11月，贵司检出(b)(4)批次(b)(4)存在微生物OOS结果。贵司从每一批次制备(b)(4)份独立样品，对其中(b)(4)份样品检测需氧菌总数，另外(b)(4)份样品检测霉菌酵母菌总数。每一批次均有一份样品超出霉菌酵母菌总数可接受标准，限值为每克不超过(b)(4)菌落形成单位。

You did not perform an appropriate investigation into the OOS results. Rather, you invalidated the OOS results by averaging the (b)(4) total yeast and mold count sample results to obtain a passing result. You also revised your microbiological sampling plan to allow for averaging of test results for component testing. This practice is not in accordance with the United States Pharmacopeia <61> test method and is unacceptable as it obscures the detection of non-uniform microbiological contamination within a lot. You subsequently released (b)(4) lots and used them in the manufacture of (b)(4) Lot (b)(4), distributed in (b)(4).

贵司未针对该OOS结果开展恰当调查，反而将(b)(4)份霉菌酵母菌检测结果取平均值，以此判定结果合格，将OOS结果作废。贵司还修订微生物取样方案，允许物料检验采用结果平均法。该做法不符合《美国药典》<61>检测方法，无法检出批次内部不均匀微生物污染，属于不可接受操作。贵司后续放行(b)(4)批次，并将其用于生产(b)(4)批次(b)(4)，该成品在(b)(4)区域分销。

Notably, on (b)(4), your customer, (b)(4), initiated a Class I recall of (b)(4) lots of (b)(4) manufactured at your facility due to potential fungal contamination in your (b)(4). The investigation associated with this recall is inadequate. For example, you implemented (b)(4) of incoming (b)(4) prior to filling to reduce bioburden, but subsequent OOS microbiological results obtained from (b)(4) lots demonstrate this corrective action was ineffective. Additionally, your change control associated with the (b)(4) process did not include ensuring appropriate validation of the process as well as evaluation of the (b)(4).

值得注意的是，在(b)(4)，贵司客户(b)(4)针对贵厂生产的(b)(4)共(b)(4)个批次启动I类召回，原因是(b)(4)存在潜在真菌污染风险。本次召回配套的调查工作不充分。举例：贵司在灌装前对进厂(b)(4)实施(b)(4)处理以降低生物负载，但后续(b)(4)批次微生物OOS结果证明该纠正措施无效。此外，(b)(4)工艺对应的变更控制，未包含工艺充分验证以及(b)(4)评估。

Further, you lacked cleaning procedures for the (b)(4) line, did not conduct cleaning validation of the (b)(4) line, and failed to include yeast and mold microbiological testing as part of your environmental monitoring program. Though your investigation into the potential fungal contamination documented an evaluation of the cleaning procedures and environmental monitoring, it did not identify nor appropriately follow-up on these risks related to potential mold contamination.

此外，贵司缺少(b)(4)生产线清洁规程，未开展该生产线清洁验证，环境监测项目也未纳入霉菌酵母菌检测。尽管贵司针对潜在真菌污染的调查记录了对清洁规程和环境监测的评估，但未能识别潜在霉菌污染相关风险，也未开展恰当的后续跟踪。

In your response to the OOS microbiological test results, you state that you plan to update your work instructions to prohibit averaging of results. You commit to conducting a retrospective review of all drug product OOS events over a (b)(4) period to identify inadequate investigations and initiate customer notifications where warranted. You also commit to engaging a consultant for root cause analysis and failure investigation training, as well as updating the change control with a risk assessment of the (b)(4).

贵司在针对微生物OOS结果的回复中称，计划更新作业指导书，禁止采用检测结果平均处理方式。承诺对(b)(4)时间段内所有药品OOS事件开展回顾性审查，识别不充分调查，必要时通知客户。同时承诺聘请顾问开展根本原因分析与偏差调查培训，并更新变更控制文件，增加(b)(4)风险评估。

Your response is inadequate. You limit the retrospective review to documented OOS events and do not extend it to all microbiological test results to identify instances in which you inappropriately applied averaging to individual failing results to obtain overall passing results. This practice potentially resulted in the improper release of drug products. Furthermore, your response lacks an adequate plan to address product quality risks. It relies solely on procedural and documentation updates without an effectiveness verification plan and fails to address the systemic quality oversight failures that allowed these practices.

贵司的回复不充分。贵司仅将回顾审查范围限定在已记录的OOS事件，未覆盖全部微生物检测结果，排查是否存在将单项不合格结果不当取平均、最终判定整体合格的情况。该操作可能造成药品违规放行。此外，回复缺少完善的产品质量风险处置方案，仅依靠规程与文件修订，无有效性验证计划，未能解决导致此类操作发生的系统性质量监管缺陷。

Inadequate investigations can lead to unidentified root causes, ineffective corrective action and preventive action (CAPA), and recurring problems that compromise the ability to manufacture safe and effective drug products. For more information about handling OOS and failing test results, and documentation of your investigations, see FDA's guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/media/158416/download. While this guidance addresses chemistry laboratory analyses, many of its principles are also relevant to investigating OOS microbiological results and out-of-trend results.

调查工作不充分，会导致无法锁定根本原因、纠正预防措施（CAPA）失效，问题反复发生，损害企业生产安全有效药品的能力。如需了解OOS、不合格结果处理以及调查文件记录相关要求，可查阅FDA指南文件《药品生产超标（OOS）检验结果调查》：https://www.fda.gov/media/158416/download。该指南虽然针对化学实验室检测，但其多数原则同样适用于微生物OOS结果以及趋势异常结果调查。

In response to this letter, provide:

针对本警告信，请提供：

A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for US products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS: o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error. o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation. o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.

对截至本警告信出具之日，在美国市场流通且尚在有效期内的销往美国产品，对所有作废OOS结果（含中间过程、放行、稳定性检验）开展独立回顾审查，并提交分析汇总报告，每一项OOS需要包含：判定作废OOS对应的科学依据与证据能否确切证明问题源于实验室误差；若调查确定根本原因为实验室问题，提供理由，并识别所有容易发生同类问题的实验室方法进行整改；回顾审查发现实验室层面无法确定或未能锁定根本原因的全部OOS结果，需要全面审查生产环节（例如批生产记录、生产步骤适用性、设备/厂房适用性、原料波动、工艺能力、偏差历史、投诉历史、批次失败历史），汇总每一项调查潜在生产根本原因以及生产改进措施。

A comprehensive review and remediation plan for your OOS and out-of-limit (OOL) result investigation systems. The CAPA should include but not be limited to addressing the following: o Quality unit (QU) oversight of laboratory investigations o Identification of adverse laboratory control trends o Resolution of causes of laboratory variation o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified o Adequate scoping of each investigation and its CAPA o Revised OOS investigation procedures with these and other remediations o A similar review and remediation of your system for handling out-of-limit findings (i.e., data that falls outside action limits)

针对OOS以及超出限度（OOL）结果调查体系开展全面审查并提交整改方案。CAPA包括但不限于：质量部门对实验室调查的监督；识别实验室管控不良趋势；解决实验室波动根源；实验室原因无法明确时，启动潜在生产原因的完整调查；每一项调查及其CAPA范围界定充分；修订OOS调查规程，纳入上述及其他整改措施；针对超出限度结果（超出行动限的数据）的管理体系，开展同类审查与整改。

A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, OOL results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted. o Furthermore, provide your (b)(4) validation study and updated cleaning procedures that demonstrate effectiveness in cleaning mold. Also provide the updated environmental monitoring study (WI-00480 Environmental Monitoring (Microbial) of Manufacturing and Laboratory Facilities Rev. 24) referenced in your response indicating sample locations, frequency, and duration, as well as alert and action limits.

对偏差、不符项、投诉、OOS、OOL及失效事件的整套调查体系开展全面独立评估，并提交详细整改行动计划。行动计划包括但不限于：调查能力、范围判定、根本原因评估、CAPA有效性、质量部门监督、书面规程的重大改进；说明贵司如何保障调查各阶段规范执行。此外，请提供(b)(4)验证研究资料以及更新后的清洁规程，证明霉菌清洁效果；同时提供贵司回复中提及的新版环境监测方案（WI-00480 生产与实验室设施微生物环境监测，版本24），载明取样点位、取样频次、监测周期、警戒限与行动限。

A comprehensive, independent assessment of the design and control of your firm's manufacturing operations with a detailed and thorough review of all microbiological hazards.

对贵司生产运营的设计与管控开展全面独立评估，完整审查所有微生物相关风险。

A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.

开展详细风险评估，评估存在潜在不合格污染的药品上市分销带来的风险，列明风险评估对应的处置措施，例如客户告知与产品召回。

Complete investigations into all batches with potential objectionable microbial contamination or an OOS microbiological result whether or not later invalidated. The investigations should detail your findings regarding the root causes of the contamination.

对所有存在潜在不良微生物污染、微生物OOS结果的批次开展完整调查，无论该OOS结果后续是否作废。调查文件需详述污染的根本原因。

A summary of results from testing retain samples of all drug product batches within expiry. You should test microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.

所有尚在有效期内药品批次留样的检验结果汇总。需要对每一批次开展微生物质量检测（总菌计数、污染菌鉴定，检出有害微生物）。若检验出现OOS结果，列明对应的纠正措施，含客户告知和启动召回。

2. Your firm's quality 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. 贵公司质量部门未能履行职责，无法保证所生产药品符合CGMP要求，满足既定鉴别、效价、质量、纯度标准（21 CFR 211.22）。

Your QU failed to adequately oversee your OTC (b)(4) drug product manufacturing operations. For example, your QU failed to:

贵司质量部门未能充分监督非处方药(b)(4)的生产活动。例如，质量部门未能：

Validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(2)).

定期验证并确认物料供应商检测结果的可靠性（21 CFR 211.84(d)(2)）。

Follow a written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).

执行书面稳定性试验方案，评估药品稳定性特征（21 CFR 211.166(a)）。

Maintain written records so that the quality standards of each drug product can be evaluated at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).

保留书面记录，确保至少每年对每种药品质量标准进行评估，判断是否需要修订药品质量标准、生产或管控规程（21 CFR 211.180(e)）。

In your response, you commit to revising your vendor evaluation and control procedure, updating your stability program master plan, and retrospectively generating stability study reports for all drug products. You also commit to updating your periodic product review procedure and completing retrospective annual product reviews for all manufactured drug products.

贵司在回复中承诺修订供应商评估与管控规程，更新稳定性总方案，补做全部药品的稳定性研究报告；同时承诺修订定期产品回顾规程，完成所有已生产药品的回顾性年度产品质量回顾。

Your response is inadequate. You did not provide supporting documentation to verify the adequacy and effectiveness of your corrective actions, nor did you address the systemic quality oversight failure that allowed deficiencies to persist undetected for multiple years, including the absence of stability study reports since 2020 and the failure to complete annual product reviews for (b)(4) of your drug products since 2024.

贵司回复不充分。贵司未提供佐证材料证明纠正措施充分有效，也未解决系统性质量管控缺陷——多项问题多年未被发现，包括自2020年起缺失稳定性研究报告，自2024年起(b)(4)类药品未完成年度产品回顾。

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company's global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.

本警告信中的重大缺陷表明贵司未能建立符合CGMP要求的有效质量体系。除生产与实验室缺少有效管理层监督外，FDA发现质量部门未能获得充分授权，且未能充分履行职责。高层管理者应立即全面评估企业全球生产运营，确保体系、工艺、产品符合FDA要求。

Your firm's quality systems are inadequate. See FDA's guidance documents ICH Q10 Pharmaceutical Quality System, at https://www.fda.gov/media/71553/download, and Quality Systems Approach to Pharmaceutical CGMP Regulations, at https://www.fda.gov/media/71023/download, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211.

贵公司质量体系不完善。如需搭建质量体系与风险管理方法，满足21 CFR第210、211部分CGMP法规要求，可参考FDA指南文件ICH Q10《药品质量体系》以及《药品CGMP法规质量体系方法》，链接分别为：https://www.fda.gov/media/71553/download 和 https://www.fda.gov/media/71023/download。

In response to this letter, provide:

针对本警告信，请提供：

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to: o A determination of whether procedures used by your firm are robust and appropriate o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices o A complete and final review of each batch and its related information before the QU disposition decision o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products

全面评估并制定整改计划，确保赋予质量部门相应权限与资源，保障其有效履职。评估内容包括但不限于：评估贵司现有规程是否稳健适用；建立质量部门全流程监督机制，核查操作合规性；质量部门在批次放行判定前，完成每一批次及相关资料完整终审；监督、审批各类调查，履行质量部门其余全部职责，保障所有产品鉴别、效价、质量、纯度达标。

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.

同时说明高层管理者如何支持质量保证与稳定运营，包括但不限于及时配置资源，主动应对新出现的生产/质量问题，持续维持受控状态。

Unapproved New Drug Violations

未经批准新药相关违规

Based on a review of the product labeling, "(b)(4)" are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from product labeling, including the product website (b)(4), that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as a drug include, but may not be limited to, the following:

经审阅产品标签，"(b)(4)"属于FD&C法案第201(g)(1)条（《美国法典》21编321(g)(1)）定义的药品，因为产品用于诊断、治愈、缓解、治疗或预防疾病，以及/或者旨在改变人体结构或机体功能。产品标签（含产品官网(b)(4)）中，可证明产品药品用途（21 CFR 201.128定义）的示例包括但不限于：

(b)(4)

Based on the above labeling evidence, (b)(4) intended for use as (b)(4) drug product. As such, these drug products are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here,1 a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

基于上述标签证据，(b)(4)拟作为(b)(4)药品使用。因此，依据FD&C法案第201(p)条（《美国法典》21编321(p)），该产品属于"新药"；在标签载明的使用条件下，该产品未被普遍认可为安全有效（GRASE）。除本案不适用的特定豁免情形外，根据FD&C法案第505(a)条（《美国法典》21编355(a)），新药若无FDA生效批准的申请，不得投放或安排投放跨州商业流通。该产品没有依据FD&C法案第505条（《美国法典》21编355）获批的有效申请。因此，该产品属于未经批准新药。将该未经批准新药投放或安排投放跨州商业流通，违反FD&C法案第301(d)条及第505(a)条（《美国法典》21编331(d)、355(a)）。

Drug Recall

药品召回

On July 22, 2026, FDA held a teleconference with you, recommending that you recall drug products manufactured with (b)(4) lots (b)(4) currently in distribution from the U.S. market. On (b)(4), your customer, (b)(4), initiated a voluntary recall of (b)(4) lots (b)(4) currently distributed within the U.S. market. The recall was posted to the FDA's Enforcement Report website at (b)(4)

2026年7月22日，FDA与贵司召开电话会议，建议贵司将使用(b)(4)批次(b)(4)生产、目前在美国市场流通的药品实施召回。在(b)(4)，贵司客户(b)(4)对在美国流通的(b)(4)批次(b)(4)启动自愿召回。该召回信息已发布于FDA执法报告网站，网址(b)(4)。

Drug Production Suspended

药品生产暂停

We acknowledge your commitment to suspend production of all drugs at this facility.

我们知悉贵司承诺暂停该厂房全部药品生产。

If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective action and preventive action, before you pursue resolution of your firm's compliance status with FDA.

若贵司计划恢复任何受FD&C法案监管的生产活动，恢复药品生产前须通知本办公室。一旦恢复CGMP相关生产，贵司必须解决全部缺陷与系统性问题，保障可持续符合CGMP。此外，基于本次查出违规事项的性质，贵司应聘请符合21 CFR 211.34资质要求的顾问协助满足CGMP要求。在贵司与FDA协商解决合规状态前，该合格顾问应对贵公司全业务开展CGMP六大系统全面审计，并评估全部纠正预防措施的完成情况与有效性。

In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.

在提交给FDA的复工通知中，提供整改汇总材料，证明贵司已妥善完成全部CAPA。

Conclusion

结论

You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

贵公司有义务开展调查，确定所有违规事项的根本原因，落实纠正和预防措施，保证未来持续合规，避免再次发生此类以及其他违规问题。

Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

违规事项若未解决，可能导致其他联邦机构不再授予合同。若未能整改违规事项，FDA还可暂停出具出口证书。在贵公司所有违规事项全部整改完毕、我方确认贵公司满足CGMP之前，FDA可能暂缓批准将贵公司列为药品生产商的新申请或补充申请。FDA可安排再次现场检查，核实贵公司已完成违规事项的整改措施。

Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3011913386 and ATTN: Renee A. Marcsisin, Ph.D. in the subject line of the email.

请在收到本函15个工作日内将书面回复发送至邮箱[email protected]。邮件主题标注FEI 3011913386，收件人：Renee A. Marcsisin博士。

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

如贵司持有相关材料，能够证明产品未违反FD&C法案及FDA法规，请一并提交供我方审阅。