FDA 于 2026 年 9 月 18 日就 Curia New York 原料药 CGMP 偏差发出警告信，涉 HPLC 无合理解释进样与碎纸筒内原始记录

2026年9月29日，FDA公布一则警告信。

检查对象：Curia New York（全球一线头部药企 CDMO）

检查日期：2026 年 1 月 28 日 至 2026 年 2 月 5 日

483回复提交时间：2026 年 2 月 27 日

FDA 警告信日期：2026 年 9 月 18 日

This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).
这封警告信概述了原料药（API）存在的严重现行药品生产质量管理规范（CGMP）偏差。

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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、包装或存放环节采用的方法、设施或管控措施不符合 CGMP 要求，根据《联邦食品、药品和化妆品法案》（FD&C Act）第 501 (a)(2)(B) 条，即《美国法典》第 21 编 351 (a)(2)(B) 条定义，贵公司的原料药属于掺伪药品。

We reviewed your February 27, 2026, response to our Form FDA 483 in detail, and we also acknowledge receipt of your subsequent correspondence.
我们已详细审阅贵公司 2026 年 2 月 27 日针对 FDA 483 表的回复，同时确认已收到贵公司后续提交的信函文件。

Violations of the Federal Food, Drug, and Cosmetic Act
《联邦食品、药品和化妆品法案》违规事项

The following are deviations identified during our inspection and review. As a reminder, this is not an all-inclusive list of deviations at your establishment.
以下是我们在现场检查与资料审阅过程中发现的偏差。特此提醒，本清单并未穷尽贵企业存在的全部偏差。

1. Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.

未能建立包含全部实验室检测完整数据的实验室控制记录，无法证明原料药及中间体符合既定质量标准与规范。

Not all electronic test results are included in your review to determine conformance of your API products.
贵公司在开展原料药产品符合性审核时，并未纳入全部电子检测结果。

Your laboratory analysts routinely conducted unexplained injections in high-performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) without adequate documentation or supervision to ensure that product samples were not being tested. Your laboratory used Empower and TotalChrom software for chromatographic data processing and analysis. Your laboratory analysts performed thousands of unexplained injections using Empower over the last 30 months, and over 70 trial injections using TotalChrom in October 2025 alone. The injections that utilized the Empower software used the “Developer” role rather than the “Operator” role without appropriate documentation. For example:
贵公司实验室分析人员常规开展无合理解释的高效液相色谱（HPLC）、超高效液相色谱（UPLC）进样操作，缺少充分记录与监督，无法确认未对产品样品开展检测。贵实验室使用 Empower 与 TotalChrom 软件进行色谱数据处理与分析。过去 30 个月内，实验室分析人员在 Empower 系统中执行了数千次无合理解释的进样；仅 2025 年 10 月，就在 TotalChrom 中执行超过 70 次试验进样。使用 Empower 软件开展的进样操作选用 “开发者（Developer）” 权限角色，而非 “操作员（Operator）” 角色，且无相应记录。举例如下：

A. Our investigators found chromatograms for testing that was performed on January 14, 2026, on chromatography equipment HPLC 49, which showed four unexplained trial injections that were injected under the “Developer” role. Your analyst confirmed these trial injections could not be traced to any product, sample, or analysis. In your response you attributed the injections to the testing of (b)(4) swab samples. Pages from the associated laboratory notebook 830-7 contained no reference to the four trial injections. Your analyst did not document any rationale for performing the trial injections using the “Developer” role in the laboratory notebook.
A. 我方调查人员发现，2026 年 1 月 14 日在 HPLC 49 色谱设备上开展检测的色谱图显示，存在四次以 “Developer” 角色执行的无合理解释试验进样。贵公司分析人员确认，这些试验进样无法追溯至任何产品、样品或分析项目。贵公司在回复中将该进样归因于 (b)(4) 擦拭取样样品检测。对应的 830-7 号实验室记录本页面中，未提及这四次试验进样。分析人员未在实验记录本中记录使用 “Developer” 角色执行试验进样的理由。

B. Your analyst conducted testing that showed two unexplained injections on February 1, 2026, on chromatography equipment UPLC 57, using the “Developer” role. Your analyst stated your QC supervisor tested (b)(4) cleaning swab samples that were reported in laboratory notebook 823-6. However, the laboratory notebook did not provide documentation on these unexplained injections.
B. 贵公司分析人员于 2026 年 2 月 1 日在 UPLC 57 色谱设备上进行检测，存在两次使用 “Developer” 角色执行的无合理解释进样。分析人员称，该操作是质量控制主管检测 (b)(4) 擦拭取样样品，相关结果记录在 823-6 号实验室记录本。但该实验记录本中，并未记录这两次无合理解释的进样。

Your response regarding these two examples states that the trial injections were performed as part of a troubleshooting exercise assisted by your quality control supervisor, and that the trial injections had no impact. However, in your retrospective review of all trial injections you identified nine injections that lacked sufficient justification and need further investigations.
贵公司针对上述两项案例的回复称，这些试验进样是在质量控制主管协助下开展故障排查工作的一部分，且试验进样未造成任何影响。但贵公司对全部试验进样开展回顾性审查后，识别出 9 次进样缺少充分理由，需要进一步调查。

You also stated in your response that nearly 20 percent of Empower trial injections were acquired or altered in “Developer” mode, which reflects inconsistent training or poor understanding of your procedure, SOP-RLS-000435. Allowing the use of the “Developer” role for analyst activities involving CGMP samples or regulated data fails to prevent analysts from performing unauthorized or undocumented sample analyses.
贵公司在回复中同时说明，近 20% 的 Empower 试验进样是在 “Developer” 模式下采集或修改数据，反映出培训不一致，或是人员对 SOP-RLS-000435 规程理解不足。允许分析人员在涉及 CGMP 样品或受管控数据的工作中使用 “Developer” 角色，无法防范分析人员开展未经授权、无记录的样品分析。

Your response is inadequate because it does not include an investigation of all unexplained injections performed to determine the associated CGMP risk, and because it does not provide an explanation of why these trial injections were performed by analysts using the “Developer” role.
贵公司本次回复不充分，原因在于：未对全部无合理解释的进样开展调查以评估对应的 CGMP 风险，也未能解释分析人员使用 “Developer” 角色执行这些试验进样的缘由。

We acknowledge your firm’s cessation of all trial injections, the removal of the “Developer” role in Empower, and your commitment to provide an additional retrospective assessment of all trial injections findings from January 2021 to October 2023.
我方认可贵公司已停止所有试验进样操作、移除 Empower 系统内的 “Developer” 角色，并承诺针对 2021 年 1 月至 2023 年 10 月期间所有试验进样相关发现开展额外回顾性评估。

In response to this letter, provide the following:
针对本警告信，请提交以下资料：

• A comprehensive, independent investigation report for all trial injections, with supporting documentation showing that the trial injections were not sample injections. If an injection is identified as a sample injection, include a determination of the impact on the distributed API materials.
  一份针对全部试验进样的完整独立调查报告，并附佐证文件，证明这些试验进样不属于样品进样。若识别某次进样属于样品进样，需评估其对已放行流通原料药物料造成的影响。

• A comprehensive, independent data-integrity assessment for all facilities, covering all computerized systems used in CGMP operations, that is, not limited to Empower and TotalChrom.
  一份覆盖全部厂区的完整独立数据完整性评估报告，涵盖 CGMP 业务中使用的所有计算机化系统，不限于 Empower 与 TotalChrom 软件。

2. Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.

质量部门未能履行职责，无法保证贵厂区生产的原料药与中间体符合 CGMP 要求。

Your Quality Unit failed to ensure adequate control over paper and electronic records. On January 29, 2026, our FDA investigator observed original laboratory records inside the shred bins maintained in your laboratory. For example, we found an original pH meter printout slip, indicating a pH reading of (b)(4); an original analytical balance printout slip, with a value of (b)(4) grams; and reviewer-signed Analytical Data Review Checklists.
贵公司质量部门未能对纸质与电子记录实施充分管控。2026 年 1 月 29 日，FDA 调查人员在贵实验室的碎纸筒内发现原始实验室记录。例如：一份 pH 计原始打印条，显示 pH 读数为 (b)(4)；一份分析天平原始打印条，数值为 (b)(4) 克；还有审核人员已签字的分析数据审核检查表。

Your response states that there was negligible impact from these discrepancies; however, your response lacks evidence to support the conclusion of negligible impact for discarding these records. Your firm could not identify who generated the pH meter printout on December 19, 2025, and why they were discarded. Your analyst discarded a balance printout weight slip dated January 25, 2026, but did not document why this balance printout slip was discarded. Furthermore, you were unable to make batch associations with the discarded original sourced documents (for example, specific batch testing).
贵公司回复称，该类偏差造成的影响可忽略不计；但回复缺少证据支撑 “丢弃记录带来的影响可忽略” 这一结论。贵企业无法确认 2025 年 12 月 19 日 pH 计打印条的生成人，以及该记录被丢弃的原因。分析人员丢弃了 2026 年 1 月 25 日天平重量打印条，但未记录丢弃该打印条的理由。此外，贵方无法将被丢弃的原始源文件关联至对应批次（例如特定批次检测）。

Without attribution of the discarded records to defined test analyses, the conclusion of negligible impact lacks an adequate evidentiary basis. Although procedure SOP-RLS-000346 was updated to require the use of instrument logbooks, your quality unit failed to investigate why the generated records were discarded in the shred bins, indicating a lack of adequate oversight. The full scope of this traceability gap is not adequately included in your response.
无法将丢弃记录归属至明确检测项目，则 “影响可忽略” 的结论缺少充分证据基础。尽管规程 SOP-RLS-000346 已更新，要求使用仪器使用日志，贵质量部门仍未调查生成的记录为何被丢弃至碎纸筒，说明监督管控不足。贵公司回复中未完整涵盖该可追溯性缺失的全部范围。

Additionally, our investigators found in the shred bin an excessive number of photocopies of your laboratory notebook pages, with CGMP activities documented. Your laboratory personnel reviewed photocopies of the original data rather than the original records, and subsequently they signed off on the original analyst notebooks without verifying any changes to the underlying data.
此外，调查人员在碎纸筒内发现大量记录 CGMP 活动的实验记录本页面复印件。贵实验室人员审核原始数据的复印件，而非原始记录；之后直接在原始分析记录本上签字，没有核验底层数据是否存在修改。

Your response acknowledges that the photocopy review practice was a direct violation of your procedure SOP-RLS-000456, requiring that all electronic primary data be reviewed and verified against the analyst's notebook.
贵公司回复承认，采用复印件开展审核的做法直接违反规程 SOP-RLS-000456，该规程要求所有电子原始数据必须对照分析人员记录本进行审核与核对。

In addition, your procedure RLS-SOP-PW-0047 GMP, “Document Storage, Control, and Retention,” requires that paper records pertaining to batch analysis be maintained. Your quality unit failed to ensure that all production control records were retained in accordance with this established procedure and failed to implement adequate controls to ensure the integrity of data generated at your facility.
另外，贵公司 GMP 规程 RLS-SOP-PW-0047《文件储存、管控与留存》要求，与批次分析相关的纸质记录必须妥善保存。贵质量部门未能确保所有生产控制记录按既定规程留存，也未落实充分管控措施，保障厂区生成数据的完整性。

We acknowledge you removed (b)(4) shred bins from the locations in building (b)(4) and transferred them under the QU control. However, your response is inadequate. Your review of shred bin data appears not to include an analysis of the contents of all the shred bins identified during the inspection. Your protocol “Review of Shred Bin Contents” identified a bin that was not included in your summary report and did not provide an explanation for this omission.
我方认可贵公司已将 (b)(4) 建筑内多处的 (b)(4) 碎纸筒移除，并交由质量部门管控。但贵公司本次回复仍不充分。贵方对碎纸筒资料的审查，似乎未包含本次检查发现的全部碎纸筒内物品分析。贵方《碎纸筒内容物审查方案》识别出一个碎纸筒，却未纳入汇总报告，且未说明遗漏原因。

Your firm had indicated that the (b)(4) bins are collected (b)(4) by a third-party service provider for off-site destruction. You are unable to determine the scope of prior discarded material from the previous document destructions.
贵企业说明，(b)(4) 碎纸筒由第三方服务商 (b)(4) 收集，运出场外销毁。贵方无法确定此前历次文件销毁中，被丢弃资料的范围。

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drug substances you manufacture. See FDA's guidance document Data Integrity and Compliance with Drug CGMP at https://www.fda.gov/media/119267/download.
贵公司质量体系无法充分保障数据的准确性与完整性，不足以支撑所生产原料药的安全性、有效性与质量。详见 FDA 指南文件《数据完整性与药品 CGMP 合规》，网址：https://www.fda.gov/media/119267/download。

In response to this letter, provide the following:
针对本警告信，请提交以下资料：

• A determination of how long the shred bin disposal of GMP documents has been occurring at your facility.
  确认贵厂区将 GMP 文件丢入碎纸筒销毁的行为持续了多长时间。

• A retrospective assessment of the scope and potential effect of the absence of instrument-use logbooks for all QC laboratory equipment over the applicable record-retention period, including an evaluation of whether any GMP testing results may be unattributable or unverifiable as a result.
  在适用记录留存期内，针对全部 QC 实验室设备，开展回顾性评估，评估缺少仪器使用日志的范围与潜在影响，包括评估是否存在因此无法归属、无法核验的 GMP 检测结果。

• A retrospective assessment of the potential scope of records that may have been improperly destroyed before the inspection, given that shred bins were collected (b)(4) with no QA review.
  鉴于碎纸筒由第三方 (b)(4) 收集且不经 QA 审核，开展回顾性评估，评估本次检查前可能被不当销毁记录的潜在范围。

• A broader data-integrity assessment, including a retrospective review of your QC laboratory operations to determine the extent to which uncontrolled documentation practices may have affected the integrity of GMP records.
  范围更广的数据完整性评估，包含 QC 实验室操作回顾审查，评估无管控文件操作对 GMP 记录完整性造成影响的程度。

• The complete final investigation report (s) regarding documents found in all shred bins. Include classification of documents, associated effect on product and manufacturing processes, and any deviation generated from the final assessment.
  针对所有碎纸筒内发现文件的完整最终调查报告。包含文件分类、对产品与生产工艺带来的相关影响，以及本次最终评估所产生的所有偏差。

• A detailed, comprehensive data-integrity investigation protocol describing how your third-party consultants will evaluate electronic data.
  一份详尽完整的数据完整性调查方案，说明贵公司第三方顾问将如何评估电子数据。

• A comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting. Your investigation should include:

针对数据、记录与报告中不准确、不一致问题的严重程度开展全面调查。调查需包含：

o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.

详细调查方案与方法；本次评估覆盖的全部实验室、生产操作、系统汇总；若拟排除部分业务环节，需提供理由。

o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.

对在职及离职员工进行访谈，确定数据不准确问题的性质、范围与根本原因。我方建议由具备资质的第三方执行访谈。

o An assessment of the extent of data-integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data-integrity deficiencies.

评估厂区数据完整性缺陷的严重程度，识别漏记、修改、删除、记录销毁、非实时补记记录及其他缺陷；描述所有发现数据完整性缺陷的厂区业务环节。

o A comprehensive, retrospective evaluation of the nature of testing data-integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where the potential breaches were identified should evaluate all occurrences.
针对检测类数据完整性缺陷性质开展全面回顾评估。我方建议，由在潜在违规领域具备专业能力的合格第三方评估全部相关事件。

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 data-integrity event and analyses of the risks posed by ongoing operations.
针对本次发现的缺陷对药品质量的潜在影响，开展现行风险评估。评估需分析：放行受数据完整性事件影响的药品给患者带来的风险，以及当前持续生产运营带来的风险。

A management strategy for your firm that includes the details of your global corrective action and preventive action (CAPA) plan. Your strategy should include: o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data, including analytical data, manufacturing records, and all data submitted to FDA. o A comprehensive description of the root causes of each data-integrity deviation, including evidence that the scope and depth of the current action plan are commensurate with the findings of the investigation and the risk assessment. Indicate whether the individuals responsible for the data-integrity breaches can still influence CGMP-related or drug-application data at your firm. o Interim measures describing the actions you have taken or will take to ensure the quality of your drugs and to protect patients, such as notifying your customers, recalling product (s), conducting additional testing, adding lots to your stability programs to ensure stability, drug-application actions, and enhanced complaint monitoring. o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (for example, training, staffing improvements) designed to ensure the integrity of your company’s data. o Confirmation that you will be hiring a data integrity compliance officer who is fully empowered to receive anonymous complaints from employees reporting data-integrity concerns, and with the authority to ensure that any potential breach is promptly investigated by an independent quality-assurance function, along with expertise from outside entities whenever needed. o A status report for any of the above activities already underway or completed.
贵公司管理策略，包含全球纠正与预防措施（CAPA）计划详细内容。该策略应包含：・详细纠正行动计划，说明贵方计划如何保障所有数据（含分析数据、生产记录、所有提交 FDA 的数据）的可靠性与完整性。・完整描述每一项数据完整性偏差的根本原因，并提供证据证明当前行动计划的范围与深度匹配调查结果与风险评估结论；说明对数据完整性违规负有责任的人员，是否仍可在贵公司影响 CGMP 相关或药品申报数据。・临时措施：描述已采取或拟采取的保障药品质量、保护患者的行动，例如通知客户、产品召回、开展附加检测、将批次加入稳定性考察项目、药品申报相关操作、加强投诉监控。・长期措施：描述各类整改工作，以及规程、工艺、方法、管控、系统、管理监督、人力资源（如培训、人员配置优化）方面的升级，用于保障企业数据完整性。・确认将聘任数据完整性合规负责人，该负责人拥有完整权限接收员工关于数据完整性问题的匿名投诉，并有权确保任何潜在违规由独立质量保障职能及时调查，必要时引入外部专业力量。・上述所有正在开展或已完成工作的进展状态报告。

3. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data.

未对计算机化系统实施充分管控，无法防范未经授权访问或修改数据。

Our investigators observed significant data-integrity violations at your facility involving the sharing of usernames and passwords that are used to gain access to your electronic computerized system for GMP analysis. For example, your electronic computerized system, (b)(4), interfaces with laboratory equipment (b)(4) and restricts access through individual, unique usernames and passwords. Despite this control, your laboratory analyst used another analyst's login credentials to conduct (b)(4) calibrations and to perform (b)(4)-sample testing.
我方调查人员在贵厂区发现严重数据完整性违规：用于登录 GMP 分析电子计算机系统的用户名与密码存在共用情况。举例：贵电子计算机系统 (b)(4) 与实验室设备 (b)(4) 对接，通过独立唯一用户名和密码限制访问。尽管设有该项管控，贵实验室分析人员仍使用其他分析人员的登录账号，执行 (b)(4) 校准以及 (b)(4) 样品检测。

The sharing of credentials constitutes a serious violation of data-integrity principles and is inconsistent with GMP requirements. Your quality system failed to detect and prevent repeated occurrences of this practice.
账号凭证共用属于严重违反数据完整性原则的行为，不符合 GMP 要求。贵公司质量体系未能发现并阻止该行为反复发生。

Your response acknowledges that your written procedure SOP-RLS-000438, “The Use of Computerized Systems for GMP Operations,” prohibited username and password sharing. Your retrospective review under Protocol RQA-P-0560 was limited to 12 stand-alone analytical instruments for the period from February 10, 2025, through February 4, 2026. This review does not encompass all computerized equipment requiring username and password access, nor does it evaluate discrepancies beyond the stated review period.
贵公司回复承认，书面规程 SOP-RLS-000438《GMP 业务计算机化系统使用规范》禁止用户名与密码共用。贵方依据 RQA-P-0560 方案开展的回顾审查，仅覆盖 2025 年 2 月 10 日至 2026 年 2 月 4 日期间 12 台独立分析仪器。该审查并未涵盖所有需要用户名密码登录的计算机化设备，也未评估上述审查时间段以外存在的偏差。

In response to this letter, provide the following:
针对本警告信，请提交以下资料：

• A retrospective review of all computerized equipment for all your facilities, including but not limited to stand-alone systems that require username and password authentication to gain access, and all products for which the equipment was used for testing, limited to distributed products currently within expiry and on the U.S. market.
  对全部厂区内所有计算机化设备开展回顾审查，包括但不限于需要用户名密码认证登录的独立系统，以及使用该设备检测、目前仍在有效期内、在美国市场流通的所有产品。

• A comprehensive, independent assessment covering all GMP-integrated computerized systems for a three-year period to fully characterize the scope of this data-integrity failure.
  开展覆盖全部 GMP 集成计算机化系统、为期三年的完整独立评估，全面厘清本次数据完整性缺陷的范围。

• A management strategy for your firm that includes the details of your global CAPA plan to implement attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.
  贵公司管理策略，包含全球 CAPA 计划详细内容，在全业务落实 ALCOA 原则（可归属、清晰、完整、原始、准确、同步记录）。详细纠正行动计划应说明贵方如何保障全部数据（包括微生物、分析数据、生产记录、所有提交至 FDA 的数据）的可靠性与完整性。

• 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.
  针对贵公司实验室操作、规程、检测方法、设备、文件记录、分析人员能力开展完整独立评估。基于本次审查，提交详细的整改计划，并评估实验室体系整改后的有效性。

Conclusion
结论

You are responsible for investigating and determining the root causes of any deviations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
贵方有责任调查并确定所有偏差的根本原因，落实纠正与预防措施，保障后续持续合规，避免本次违规以及其他同类问题再次发生。

Unresolved deviations may prevent other Federal agencies from awarding contracts. Failure to address deviations 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 deviations 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 deviations.
未解决的偏差可能导致其他联邦机构无法授予合同。若未能处理偏差，FDA 还可暂停出具出口证书。在偏差全部整改完毕、我方确认贵方符合 CGMP 之前，FDA 可暂缓批准将贵企业列为药品生产厂的新申报或补充申报。FDA 可实施再次检查，核实贵方已完成偏差相关纠正措施。

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately at [email protected], so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356c (b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.
若贵方拟采取的行动可能造成贵厂区药品供应中断，FDA 要求贵方立即通过邮箱 drugshortages@fda.hhs.gov 联系 CDER 药品短缺工作组，以便 FDA 与贵方协作，采取最有效的方式使贵业务运营符合法规要求。联系药品短缺工作组，也可帮助贵方履行《美国法典》21 编 356c (b) 条规定的药品停产、生产中断报告义务。同时便于 FDA 尽快评估是否需要采取相关措施，避免药品短缺，保护依赖贵产品的患者健康。