FDA公布对VeganicSKN Limited的警告信，指出OOS调查与物料鉴别缺陷并提及两家企业共用生产场地与系统

近日，FDA公布一则VeganicSKN Limited的一封警告信。

检查对象：VeganicSKN Limited

检查日期：2025 年 7 月 15 日至 21 日

483回复提交时间：2025 年 8 月 11 日

FDA 警告信日期：2026 年 2 月 9 日

66-40（进口禁令）：2026 年 1 月 9 日

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, VeganicSKN Limited, FEI 3024609429, at 81 Shettleston Street, Unit III, Rocklea, Queensland, Australia, from July 15 to 21, 2025.
美国食品药品监督管理局（FDA）于 2025 年 7 月 15 日‑21 日，对贵司位于澳大利亚昆士兰州罗克利市谢特莱斯顿街 81 号 III 单元，FEI 编号 3024609429 的药品生产工厂 VeganicSKN Limited 开展现场检查。

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).
本警告信汇总了成品药品现行药品生产质量管理规范（CGMP）的重大违规情形。请参阅《美国联邦法规》第 21 篇第 210、211 部分（21 CFR parts 210 and 211）。

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).
由于贵司用于生产、加工、包装或储存的方法、设施或管控措施不符合 CGMP 要求，依据《联邦食品、药品和化妆品法案》（FD&C Act）第 501 (a)(2)(B) 条（美国法典第 21 编 §351 (a)(2)(B)），贵司生产的药品属于劣药。

We reviewed your August 11, 2025, response to our Form FDA‑483 in detail, and we acknowledge receipt of your subsequent correspondence.
我方已详细审阅贵司 2025 年 8 月 11 日针对 FDA‑483 检查报告的回复，并确认已收到贵司后续往来函件。

During our inspection, our investigator observed specific violations, including but not limited to the following.
检查过程中，我方检查员发现多项具体违规，包括但不限于如下内容。

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).

无论批次是否已经对外放行，贵司未能对批次或其组分未达到质量标准的无法解释的偏差或不合格结果开展充分调查（21 CFR 211.192）。

Your firm failed to conduct an adequate and timely out‑of‑specification (OOS) investigation for your (b)(4) drug product. Your contract testing laboratory reported an OOS result for (b)(4) on August 28, 2024, but you did not initiate the Phase II investigation until December 4, 2024. Despite the ongoing investigation, your quality unit (QU) released the batch on (b)(4), and subsequently shipped the batch for the U.S. market on (b)(4), after your firm retested the sample and obtained passing results. A root cause was not determined for the OOS result, and the investigation was closed on July 11, 2025.
贵司未针对贵司 (b)(4) 药品及时开展充分的超标（OOS）调查。贵司委托的检测实验室于 2024 年 8 月 28 日报告 (b)(4) 项目出现 OOS 结果，但贵司直至 2024 年 12 月 4 日才启动 II 阶段全面调查。调查尚在进行过程中，贵司质量部门（QU）在重新检测样品得到合格结果后，于 (b)(4) 放行该批次，并于 (b)(4) 将该批次发往美国市场。本次 OOS 结果未查明根本原因，调查便于 2025 年 7 月 11 日予以关闭。

In your response, you state that you opened a corrective action and preventive action (CAPA) plan that includes updating your procedure for releasing drug products, and you conducted a risk assessment to determine the final disposition of this lot, which is still within expiry and any subsequent market action.
贵司在回复中表示，已启动纠正预防措施（CAPA）计划，其中包括更新药品放行操作规程；并且开展风险评估，确定该仍在有效期内批次的最终处置方案以及后续市场处置措施。

Your response is inadequate because it fails to provide a justification for not completing your OOS investigation for nearly 11 months. Additionally, while you state that the OOS drug product was shipped because of a breakdown in your drug product‑release procedure, you did not determine the root cause for the actual OOS result, nor did you conduct a comprehensive assessment of your quality system to ensure that all OOS investigations have been adequately investigated.
贵司的回复不充分，未能解释为何 OOS 调查拖延近 11 个月仍未完成。此外，尽管贵司称该 OOS 药品发运是由于药品放行流程失效，但既未查明该 OOS 结果的实际根本原因，也未对质量体系开展全面评估，以确认全部 OOS 调查均已得到充分处置。

Inadequate investigations can lead to unidentified root causes, ineffective CAPAs, and recurring problems that compromise your ability to manufacture safe and effective drug products.
调查工作不充分将导致根本原因无法识别、CAPA 措施失效，问题反复发生，损害贵司生产安全有效药品的能力。

For more information about handling failing, OOS, out‑of‑trend, or other unexpected 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/71001/download.
如需要了解不合格、OOS、超趋势以及其他异常结果的处置和调查文件相关更多信息，请查阅 FDA 行业指南《药品生产超标（OOS）检验结果的调查》：https://www.fda.gov/media/71001/download。

In response to this letter, provide:
请就本函提供如下资料：

• A retrospective, independent review of all invalidated OOS (including in‑process and release/stability testing) results for U.S. 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:

• 对截至本函出具之日，仍在美国市场流通且尚在有效期内的销往美国的全部产品，对所有被作废处理的 OOS 结果（包括中间过程、放行、稳定性检测）开展独立回顾性审查，并提交分析总结报告。每一项 OOS 均需要包含以下内容：

o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.

○ 判断被作废 OOS 结果对应的科学依据与证据，是否可以明确证明该异常系实验室误差导致；

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.

○ 若调查已经明确根本原因为实验室问题，提供理由说明，并识别所有易发生同类根本原因的其他实验室检测方法，制定整改措施；

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.
○ 经回顾审查，若 OOS 结果无法判定、或未查明实验室层面根本原因，则需要对生产环节开展全面审查（例如批生产记录、生产步骤的充分性、设备与设施适用性、原料波动、工艺能力、偏差历史、投诉历史、批次失败历史），总结每起调查潜在的生产根本原因，以及对应的生产工艺改进方案。

• A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:

• 针对贵司 OOS 调查体系提交全面审查及整改计划。CAPA 应当包括但不限于以下内容：

o QU oversight of laboratory investigations

○ 质量部门对实验室调查工作的监督管控；

o Identification of adverse laboratory control trends

○ 识别实验室管控的不良趋势；

o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified

○ 无法明确判定原因为实验室问题时，启动针对潜在生产原因的全面调查；

o Resolution of causes of laboratory variationsInitiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified

○排查并解决实验室偏差的各类诱因；当无法明确判定问题源于实验室因素时，需针对潜在生产诱因开展全面调查。

o Adequately scoping of each investigation and its CAPA

○ 每一起调查及其 CAPA 的范围界定应当充分完整；

o Revised OOS investigation procedures with these and other remediations.
○ 结合上述整改及其他改进内容，修订 OOS 调查操作规程。

2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).

贵司未能对药品每种组分开展至少一项鉴别试验；同时也未能定期验证确认物料供应商检测分析结果的可靠性（21 CFR 211.84 (d)(1)、211.84 (d)(2)）。

Your firm did not adequately test your incoming component, (b)(4), for identity prior to use in manufacturing. (b)(4) is a component that is at high risk for (b)(4) contamination. Your firm also accepted the (b)(4) raw material based on the supplier’s certificate of analysis (COA), without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals. Additionally, the (b)(4) lot you utilized for drug product production had expired.
贵司将物料 (b)(4) 投入生产前，未对该进厂物料开展充分的鉴别检验。该物料 (b)(4) 存在 (b)(4) 污染高风险。贵司仅凭供应商分析报告（COA）接收 (b)(4) 原料，没有定期确认各物料供应商检测数据的可靠性。此外，用于药品生产的该批 (b)(4) 物料已经过期。

In your response, you state that you opened a CAPA, performed a risk assessment, and sent all remaining drums of (b)(4) out for testing. In addition, you state that your firm is evaluating the (b)(4) of your (b)(4) products to a lower‑risk excipient, to eliminate supply chain risk in all future productions.
贵司在回复中称，已启动 CAPA、完成风险评估，并将剩余全部桶装 (b)(4) 送外检测。同时贵司表示，正在评估将 (b)(4) 产品中的 (b)(4) 替换为低风险辅料，消除后续生产的供应链风险。

Your response is inadequate. Your risk assessment is theoretical. You conclude that the risk is low based on (b)(4) and (b)(4) application. You did not correlate the assessment to the actual test results for all affected lots. Additionally, your firm acknowledges that identity testing based on supplier COA plus FTIR was inadequate for high‑risk materials like (b)(4), yet you still reference past acceptance decisions as part of your justification. Acknowledging the gap does not mitigate the fact that your product was released under a flawed system, without appropriate controls in place at the time. Further, while you describe retrospective testing of remaining drums, there is no clear discussion of drug product that had already been manufactured and potentially distributed using untested (b)(4). There is no mention of an impact assessment or of any market action.
贵司回复并不充分。贵司风险评估仅停留在理论层面，依据 (b)(4) 以及 (b)(4) 用途判定风险较低，未将评估结果与全部受影响批次的实际检测结果相结合。此外，贵司承认对于 (b)(4) 这类高风险物料，仅依靠供应商 COA 加傅里叶变换红外光谱的鉴别手段并不充分，但仍引用过往放行决策作为辩解理由。仅仅认识到管控漏洞，并不能改变产品在管控体系存在缺陷、缺少必要控制的条件下放行的事实。另外，贵司仅描述了剩余桶装物料的回溯检测，但未明确说明已经使用未经充分检测的 (b)(4) 生产、并且可能已经分销的成品药品，也未提及影响评估以及市场处置措施。

While your response states that you will reformulate your finished drug products to remove (b)(4), it lacks a retrospective assessment with supporting analytical testing for products containing materials at high risk for (b)(4) contamination that are still on the market and within expiry. Furthermore, your response did not include an assessment of your drug products to identify other components at risk for (b)(4) contamination and proposed corrective actions. Your response also lacks your interim plans, controls, or risk‑mitigation strategies until you reformulate your finished drug products.
虽然贵司回复表示将调整制剂处方去除 (b)(4)，但缺少针对目前仍在市场流通、有效期内，含有 (b)(4) 污染高风险物料产品的回溯评估以及配套检测数据。并且，回复未评估药品中其他存在 (b)(4) 污染风险的组分，也未提出对应的纠正措施。同时也未提供处方变更完成前的过渡方案、管控手段和风险降低策略。

Identity testing for (b)(4) and certain other high‑risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for (b)(4) levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.
针对 (b)(4) 以及其他部分高风险药品组分，美国药典（USP）鉴别项下包含限度检查，以确保物料中 (b)(4) 杂质水平符合安全限度。贵司未采用可检出该危险杂质的 USP 鉴别方法对每一批次每一批到货物料开展检验，无法保证用于药品生产的物料符合使用要求。

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high risk for (b)(4) contamination at (b)(4)
全球范围内，使用被 (b)(4) 污染的辅料已造成多起人类中毒致死事件。请查阅 FDA 行业指南 (b)(4)，获取生产含有 (b)(4) 污染高风险组分药品时满足 CGMP 合规的相关指引 (b)(4)。

In your response to this letter, provide:
请就本函提交如下资料：

• A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high‑risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4).
  承诺自本函日期起 30 个自然日内，提交所有用于药品生产的高风险物料留样的 (b)(4) 检测结果。如物料批次留样已不可获取，则对全部涉事成品批次开展 (b)(4) 项目留样检测。

• A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component (s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
  对有效期内含有 (b)(4) 污染风险组分（包括但不限于 (b)(4)）的全部药品完成完整风险评估。迅速采取恰当行动，评估相关物料以及可能受污染药品的安全性；若确认批次受污染，需要包含客户通知、产品召回等处置。制定可保障未来供应链安全的其他 CAPA 措施，包括但不限于确保进厂原料全部来自经过充分确认的生产商，原料不含危险杂质。请在回复中详细说明以上行动。

• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation and periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4), and certain additional high‑risk components, we note that this includes the performance of parts A, B, and C of the USP monograph.
  说明贵司如何对每一批物料开展检验，确认鉴别、含量、质量、纯度全部符合标准。如贵司计划采信供应商 COA 结果，而不对每批物料检验含量、质量、纯度，请说明将如何通过初始验证以及定期再验证，充分证实供应商检测结果的可靠性。同时，承诺对每一批进厂物料均至少执行一项专属鉴别试验。针对 (b)(4) 及其他部分高风险物料，需执行美国药典各论 A、B、C 全部检测项目。

• The chemical quality control specifications you use to test each incoming lot of high‑risk drug components to determine their acceptability for use in manufacturing.
  提供用于判定每一批进厂高风险物料是否可投入生产的化学质量控制标准。

• A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are each qualified, and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
  对贵司物料管理体系开展全面独立审查，确认所有物料、内包材供应商均经过资质确认，物料均设置合理有效期或复检期。同时评估进厂物料管控措施是否足以避免不合格物料、包材投入使用。

• A summary of your program for qualifying and overseeing contract facilities that test the components you use to manufacture your drugs.
  总结贵司针对物料委托检测机构的资质确认与监督管理程序。

• A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
  汇总用于评估各物料生产商 COA 可靠性的全部物料检测结果，并提供描述 COA 验证工作的标准操作规程（SOP）。

3. 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).

贵司质量部门未能履行职责，无法保证生产的药品符合 CGMP，且满足既定的鉴别、含量、质量与纯度标准（21 CFR 211.22）。

Your QU did not adequately exercise its authority and responsibilities, including but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU failed to ensure:
贵司质量部门没有充分行使权限、履行职责，包括但未能执行有效的操作规程，对生产的药品实施充分监督。举例，质量部门未能做到：

• Establishment of adequate procedures describing their roles, responsibilities, authorities, and oversight (e.g., production personnel perform functions that should be QA responsibilities (21 CFR 211.22 (a) and 21 CFR 211.22 (d)).
  建立充分的操作规程，明确质量部门的角色、职责、权限与监督义务；例如出现生产人员承担本应属于质量部门的工作（21 CFR 211.22 (a)、21 CFR 211.22 (d)）。

• That production and process control procedures are designed to assure the quality of drug products (e.g., completion of bulk hold time validation studies) (21 CFR 211.100 (a)).
  生产与过程控制操作规程的设计能够保障药品质量（例如完成中间产品存放时限的验证研究）（21 CFR 211.100 (a)）。

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations (21 CFR parts 210 and 211) at https://www.fda.gov/media/71023/download.
贵司质量体系存在缺陷。请参考 FDA 行业指南《面向药品 CGMP 法规的质量体系方法》，该指南可协助建立质量体系、风险管理，满足 21 CFR parts 210 and 211 CGMP 法规要求：https://www.fda.gov/media/71023/download。

In response to this letter, provide a comprehensive assessment and remediation plan to ensure that your QU is given the authority and resources to function effectively. The assessment should also include but not be limited to:
请回复本函，提交全面评估与整改计划，保证质量部门被赋予充分权限与资源，能够有效履职。评估内容应当包括但不限于：

• A determination of whether procedures used by your firm are robust and appropriate
  评估贵司现有操作规程是否完备、适用。

• Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
  建立制度，使质量部门能够贯穿全流程开展监督，评估各项操作是否符合规范。

• A complete and final review of each batch and its related information before the QU disposition decision
  质量部门在做出批次处置决定前，对每一批次及全部相关信息开展完整终审。

• Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
  监督并批准各类调查工作，落实质量部门全部职责，保证所有产品的鉴别、含量、质量、纯度符合要求。

(b)(4)
(b)(4)

FDA identified significant concerns regarding the (b)(4), which appear to operate as closely integrated entities despite maintaining separate corporate identities. Both firms share the same physical location, use common manufacturing operations (utilities, equipment, document management system), and employ overlapping personnel, including key management oversight positions. This level of operational integration raises questions about the independence of your respective quality systems and regulatory compliance programs. Given that (b)(4), the shared resources and management structure between your firms create the potential for a risk that compliance deficiencies may be transferred or propagated across both organizations. The lack of clear operational separation between (b)(4) diminishes confidence in your ability to maintain independent quality‑assurance functions and to implement effective corrective‑action systems.
FDA 发现针对 (b)(4) 的重大关切：两家主体虽为相互独立法人，但实际运营高度一体化。两家企业共用同一处生产场地，共享生产运行系统（公用工程、设备、文件管理系统），关键管理监督岗位人员交叉任职。如此深度的业务一体化，引发对双方质量体系、合规体系独立性的质疑。鉴于 (b)(4)，两家企业共享资源与管理架构，存在合规缺陷在两家机构之间传导扩散的风险。双方缺少清晰的业务隔离安排，削弱监管方对贵司能够维持独立质量保证职能、落地有效纠正措施体系的信任。

Clarify the nature of this relationship and demonstrate how each entity maintains distinct and adequate control over its manufacturing operations, quality systems, and regulatory compliance responsibilities.
请说明该关联关系的实质，并证明两家法人主体如何分别对自身生产运营、质量体系、合规义务保持独立且充分管控。

CGMP Consultant Recommended
建议聘请 CGMP 顾问

We acknowledge that you have engaged a consultant to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should be qualified as set forth in 21 CFR 211.34 and should perform a comprehensive six‑system audit of your entire operation for CGMP compliance, and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
我方知悉贵司已聘请顾问评估工厂运营，协助满足 CGMP 要求。该顾问应当符合 21 CFR 211.34 规定的资质；在与 FDA 推进合规状态整改闭环前，顾问需要完成覆盖六大系统的 CGMP 全面审计，评估全部 CAPA 措施的完成情况与实施有效性。

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
聘请顾问并不能免除贵司遵守 CGMP 的法定义务。贵司高级管理层仍对消除全部缺陷与体系漏洞、持续满足 CGMP 合规承担全部责任。

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 any violations and for preventing their recurrence or the occurrence of other violations.
本信列举的违规项并未穷尽工厂现存全部问题。贵司有义务调查确认所有违规的根本原因，防范同类或其他违规再次发生。

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66‑40 on January 9, 2026.
FDA 已于 2026 年 1 月 9 日将贵司拟进口至美国的全部药品列入《进口预警 66‑40》。

Correct any violations promptly. 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 any violations.
请立即整改全部违规。在贵司全部违规得到彻底解决、FDA 确认 CGMP 合规前，FDA 可暂缓批准将贵司列为生产场地的新申报或补充申请。FDA 将安排再次现场检查，核实贵司整改措施落实情况。

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at VeganicSKN Limited, located at 81 Shettleston Street, Unit III, Rocklea, Queensland, into the United States under section 801 (a)(3) of the FD&C Act, 21 U.S.C. 381 (a)(3). Articles under this authority that appear to be adulterated may be detained or refused 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).
若贵司未能完成缺陷整改，依据《联邦食品、药品和化妆品法案》801 (a)(3) 条（美国法典 21 编 §381 (a)(3)），FDA 可持续拒绝 VeganicSKN Limited（澳大利亚昆士兰州罗克利市谢特莱斯顿街 81 号 III 单元）生产的产品进入美国。如产品因生产方法、管控手段不符合 FD&C Act 501 (a)(2)(B) 条（21 U.S.C. 351 (a)(2)(B)）CGMP 要求而被判定为劣药，产品可被扣留或拒绝入境。

This letter notifies you of our findings and provides you with an opportunity to address the deficiencies above. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
本函向贵司通报检查发现，并给予贵司整改上述缺陷的机会。请贵司收到本函后，15 个工作日内向本机构书面回复，说明已完成的整改行动及预防缺陷复发的措施。回复中可提交补充资料，供我方评估贵司运营情况参考。若 15 个工作日内无法完成全部整改，请说明延期理由以及完整的整改完成时间计划。