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Warning Letter 320-20-45
August 24, 2020
Dear Mr. Jain:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, PT. MegaSurya Mas, FEI 3007801999,at J1 Tambak Sawah 32, Sidoarjo, Jawa Timur, from November 11 to 15, 2019.
美国FDA于2019年11月11日至15日检查了你们位于印尼的PT. MegaSuryaMas, FEI 3007801999生产场所。
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 product is 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。
We reviewed your December 7, 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12月7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：
1. You 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 and your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(a) and (e)). 你公司未在放行之前对每批药品进行适当的实验室检测，确定其满足药品的最终质量标准，包括每种活性成分的鉴别和含量；并且你公司未建立这些检测方法的准确度、灵敏度、专属性和重复性（21 CFR 211.165(a)和(e)）。
Inadequate testing before release 放行前检测不足
Your firm released and distributed the over-the-counter (OTC) drug product, (b)(4), to the U.S. on (b)(4), without adequate final product testing. Your batch (b)(4) release document, dated August 14, 2019, recorded an assay result of (b)(4)% (specification (b)(4) – (b)(4)%) of (b)(4). You acknowledged during the inspection that this test was performed in November 2019, after the date of the release document and after the release of the drug product. This discrepancy on batch release documents demonstrates a concern regarding the validity in your CGMP records.
你公司放行销售了OTC药品XX至美国，却未执行足够的最终产品检测。你们的批放行文件（日期20190814）记录了一个含量结果为XX%（质量标准为YY-ZZ%）。你们在检查期间承认该检测是在2019年11月执行的，是在放行文件签署日期后面，在产品放行之后。批放行文件的日期差异引发对你们CGMP记录的有效性担忧。
Inadequate Method Validation 方法验证不足
Your firm lacked appropriate validation (or verification, for United States Pharmacopeia (USP) compendial methods) of your analytical test methods used to determine acceptability of your drug product before release for distribution.
你公司对用于在放行销售之前确定你们药品可接受度的分析方法未进行适当验证（或确认，如为USP方法）。
During the inspection, your firm acknowledged that the assay testing for the active ingredient in your finished product is not an USP method, nor has the method been validated for testing by high-performance liquid chromatography (HPLC).
在检查期间，你公司承诺你们制剂中所用的活性成分含量HPLC检测并不是USP方法，亦未经过验证。
Analytical methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. Verifying the accuracy, sensitivity, specificity, and reproducibility of your test methods is essential to determine if the drug products you manufacture meet established specification for chemical and microbial attributes.
分析方法必须进行验证才能证明其适合其既定用途，并且等同或优于适用的USP药典方法。如果要确定你们生产的药品是否符合既定的化学和微生物属性标准，则必须对你们的检测方法准确性、灵敏度、专属性和重复性进行核查。
In your response, you stated that you will purchase a reference standard for the active ingredient, (b)(4), and you will perform validation for specified methods. You also stated that you will perform testing for remaining stock of the (b)(4) by April 30, 2020.
在你们的回复中，你们声称你们会购买活性物质对照品，对指定的方法进行验证。你们还声称你们会在2020年4月30日之前对库存的XX进行检测。
Your response is inadequate because you did not address your failure to perform adequate release testing on your finished drug products. You also did not provide sufficient information regarding the validation or verification of your test methods for identity and strength of (b)(4). Additionally, your firm lacked a comprehensive assessment and retrospective review of all data generated from all computerized laboratory systems used in CGMP operations.
你们的回复是不充分的，因为你们并未解决你们未对药品进行足够的放行检测的问题。你们亦未提交足够的信息说明你们XX鉴别和剂量的检测方法的验证或确认情况。另外，你们公司亦未对所有CGMP操作中所用的计算机化实验室系统中生成的所有数据进行回顾审查。
In response to this letter, provide the following:
在回复本函时请提交以下资料：
• 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.
• 对你们实验室规范、程序、方法、仪器、文件和化验员能力的全面独立评估。根据该审核结果，提交一份详细的补救计划，并评估你们实验室系统的有效性
• A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before batch disposition decisions.
• 一份化学和微生物质量标准的清单，包括用于批处置决策之前分析你们每批药品检验方法，
An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States within expiry.
一份对留样执行全部化学和微生物检测的行动计划和时间表，以确定销售至美国但仍在有效期内的所有药品批次的质量
A summary of all results obtained from testing retain samples from each batch. If such testing reveals substand ard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
对每批留样检测所得结果的汇总。如果检测发现有不合格的药品，快速采取纠正措施，例如通知客户和召回产品
• The actions you will take to determine the overall quality of your U.S. drug product batches within expiry which were previously released without adequate testing, including identity and strength of active ingredients.
• 为确定你们之前未进行充分检测已放行的仍在效期内美国产品的总体质量，你们准备采取的措施，包括对活性成分的鉴别和剂量检测
• Validation summary of all analytical methods you will use to test each batch of U.S. drug product for identity, strength, quality, and purity.
• 对你们准备用于检测每批美国药品的鉴别、剂量、质量和纯度的所有分析方法的验证摘要
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 suppliers test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).你公司未对药品的每种组份执行至少一项鉴别。你公司亦未以适当时间间隔验证和建立你们组份供应商的检测分析可靠性（21 CFR 211.84(d)(1) and (2)）。
You failed to test the incoming active pharmaceutical ingredient (API), (b)(4), you use in manufacturing your drug product to determine conformance to identity, purity, strength, and other appropriate specifications. Instead, you released API for use in drug production based solely on certificates of analysis (COA) from your supplier without establishing the reliability of the suppliers analysis through appropriate validation and ensuring that at least one specific identity test is conducted for each lot.
你们未检测用于你们药品生产的进厂API，以确定其符合鉴别、纯度、剂量和其它适当的标准。相反，你们仅根据你们供应商的COA就放行了API用于药品生产，并未通过适当的验证建立起供应商分析的可靠性，亦未能确保对每个批次至少进行一项专属性鉴别检查。
In your response, you stated that you will purchase a (b)(4) reference standard, and you will perform identity testing for the existing stock of API.
在你们的回复中，你们声称你们会购买XX对照品，对现有API库存进行鉴别测试。
Your response is inadequate because you failed to commit to test all new incoming lots of raw material before you use it in the manufacture of your drug products. In addition, you did not specify how you will establish the reliability of your suppliers analyses. Also, you did not take any action for drug products already in the market.
你们的回复是不充分的，因为你们并未承诺对所有新进批次原料在用于药品生产之前进行检测。另外，你们亦未说明你们要如何建立你们供应商分析的可靠性。你们亦未对在售药品采取任何措施。
In response to this letter, provide the following:
在回复本函时请提交以下资料：
• 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.
• 一份对你们原料管理系统的全面独立审核，从而确定是否所有组份、容器和密闭器的供应商均经过批准，原料是否给定了适当的有效期或复验期。审核还应确定进厂物料的控制是否足以防止使用不当的组份、容器和密闭器
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
• 你们在将物料用于生产之前检测和放行每批进厂组份的化学和微生物质量控制标准
• 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 COA 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 as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
• 说明你们要如何检测每批组份，确定其是否符合所有恰当的鉴别、剂量、质量和纯度标准。如果你们准备接受你们供应商COA的所有结果，而不对每批组份的剂量、质量和纯度进行检测，那么说明你们准备如何通过初次验证和定期再验证切实建立起你们供应商结果的可靠性。另外，要提交一份承诺，承诺会对每批进厂组份执行至少一项专属性鉴别检查
• 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.
• 一份对所有组份进行检测所得结果的汇总，以评估来自各组份生产的COA可靠性。要提交一份你们说明该COA验证计划的SOP
• A summary of your program for qualifying andoverseeing contract facilities that test the drug products you manufacture.
• 一份你们确认和监管你们所生产的药品检测合同场所的程序摘要
3. Your firm failed to follow 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(b)). 你公司未遵守书面的生产和工艺控制程序，这些程序是设计用来确保你们所生产的药品具备其理当或宣称具备的鉴别、剂量、质量和纯度的（21 CFR 211.100(b)）。
Your firm failed to execute your process validation procedure for your drug product, (b)(4). Additionally, your firm failed to validate your (b)(4) system and cleaning program.
你公司对你们的药品XX未执行你们的工艺验证程序。另外，你公司未验证你们的XX系统和清洁程序。
Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established.
工艺验证评估的是工艺设计的合理性和整个生命周期中的受控状态。每个关键的生产工艺步骤均必须进行恰当设计，确保原料输入、中间体和成品的质量。工艺确认研究决定了是否建立起初始的受控状态。
Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance document, Process Validation: General Principles and Practices, for general principles and approaches that FDA considers appropriate elements of process validation athttps://www.fda.gov/media/71021/download.
在商业销售之前必须有成功的工艺确认研究。之后，对工艺性能和产品质量必须进行严格监管，从而确保你们在产品生命周期中维护稳定的生产操作。参见FDA的工艺验证指南。
In your response, you stated that you will perform process validation. In addition, you indicated that you have a plan to redesign your (b)(4) system and have a proposed qualification protocol in place. Also, you indicated that you have established a cleaning validation protocol and will conduct studies.
在你们的回复中，你们声称你们会执行工艺验证。另外，你们说你们有计划重新设计你们的XX系统，并已订出了确认方案。你们还说你们已制订了清洁验证方案，会进行研究。
Your response is inadequate because it lacked sufficient information on your planned validation activities, includingtimelines for completion. Furthermore, you did not address the effects of yourlack of process validation on the products in the market within expiry.
你们的回复是不充分的，因为回复缺少你们所计划的验证活动的足够信息，包括完成时间表。另外，你们并未说明你们没有进行工艺验证对在售效期内药品的影响。
In response to this letter, provide the following:
在回复本函时请提交以下资料：
• A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
• 一份对你们验证计划和相关程序的详细摘要，从而确保整个产品生命周期的均处于受控状态。说明你们的工艺性能确认计划，持续监测批间和批内波动性，确保工艺持续受控
• A timeline for performing appropriate process performance qualification (PPQ) for each of your marketed drug products.
• 一份对你们所有已上市药品执行工艺性能确认（PPQ）的时间表
• Your process performance protocol(s), and writtenprocedures for qualification of equipment and facilities.
• 你们的工艺性能方案和书面设备与设施确认程序
• A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
• 你们所有生产工艺的设计、验证、维护、控制和为了确保持续受控状态的监测详细计划，包括严格的批内和批间波动监测。还要提交你们的设备和设施确认计划。
• A comprehensive remediation plan for the design, control, and maintenance of the (b)(4)system. Include a validation report for the (b)(4) system obtained after an appropriately designed system has been installed. Include the system validation protocol, the complete test results, and the final validation report.
• XX系统的设计、控制和维护全面补救计划，包括XX系统在适当设计适当安装之后的验证报告。包括系统验证方案，完整的测试结果和最终验证报告。
• Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your products.
• 你们监控该系统是否产出适合用于你们产品的XX时所用的总微生物计数限度
• A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
• 一份详细的风险评估，解决所发现的XX系统失败对所有目前在美国销售且在效期内的药品质量的潜在影响。说明你们为响应该风险评估而准备采取的措施如通知客户和召回产品
• A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
• 你们XX系统监测的程序，注明XX的日常微生物检测，从而确保其可用于你公司所生产每批药品
• A summary of updated SOPs that ensure anappropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
• 更新后的SOP的摘要，确保制订了恰当的程序核查和验证产品、工艺和设备清洁程序
• A corrective and preventive action (CAPA) plan, based on the retrospective assessment, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning.
• 基于回顾性评估制订的CAPA计划，其中要包括对你们深深地工艺和做法的恰当补救，以及完成时间限。提交一份你们设备清洁工艺生命周期管理的薄弱点的详细摘要。说明你们清洁程序的改进情况，包括清洁有效性改进情况、改进后的持续清洁核查
4. Your firms 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). 你公司的质量部门未能履行其职责从而确保所生产的药品符合CGMP要求，并符合既定的鉴别、剂量、质量和纯度标准（21 CFR 211.22）。
Your firm lacked an adequate quality unit (QU). For example, your quality unit failed to establish procedures describing QU roles, responsibilities, and authorities. Furthermore, your QUs oversight of your drug manufacturing operations were inadequate. For example, your QU failed to perform the following:
你公司没有足够的质量部门。例如，你们质量部门没有制订程序说明QU角色、职责和权力。而且你们QU对药品生产操作的监管是不足的。例如，你们QU未履行以下职责：
• Establish Master Batch records.
• 制订主批记录
• Control and issue batch records.
• 控制和发放批记录
• Oversee laboratory controls for computerizedsystems.
• 监管实验室的计算机化系统
• Evaluate discrepancies and out-of-specification results.
• 评估不符合情况和OOS结果
In your response, you stated that you wrote aprocedure for QU responsibilities, performed training, and installed a security system.
在你们的回复中，你们声称你们有写过一份QU职责的程序，进行了培训，并安装了保安系统。
Your response is inadequate because it lacked a commitment to test batches currently in the market to ensure the product meets the quality attributes throughout its expiry.
你们的回复是不充分的，因为你们没有承诺对当前在售批次进行检测，从而确保产品在其有效期内符合质量属性要求。
In response to this letter, provide a comprehensiveassessment and remediation plan to ensure your QU is given the authority andresources to effectively function. The assessment should also include, but notbe limited to:
在回复本函时，请提交一份全面的评估和补救计划，确保你们QU被授予了权力，给予了资源，能够有效履行职责。评估还应包括但不仅限于：
• A determination of whether procedures used by yourfirm are robust and appropriate.
• 确定你公司所用的程序是否稳健恰当
• Provisions for QU oversight throughout youroperations to evaluate adherence to appropriate practices.
• QU监管你们所有操作评估是否遵守恰当规范的条款
• A complete and final review of each batch and its related information before the QU disposition decision.
• 在QU做出批处置决策前对每个批次及其相关信息进行完整最终评估
• Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
• 监管和批准调查以及履行所有其它QU义务，从而确保所有产品的鉴别、剂量、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.
另外，要说明高级管理层是如何支持质量保证和可靠运行的，包括但不仅限于及时提供资源，主动解决新发现的生产/质量问题，确保持续受控状态。
5. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR211.166(a)). 你公司未建立和遵守足够的书面检测程序，设计用以评估药品的稳定性特性，以及使用稳定性测试结果确定适当的存贮条件和有效期（21 CFR 211.166(a)）。
You have an inadequate stability program for your drug product. During the inspection, it was noted that there were no procedures or protocols for performing accelerated or long-term stability testing on drug products.
你们的药品稳定性计划不充分。在检查期间，我们注意到没有药品实施加速或长期稳定性测试的程序或方案。
In your response, you stated that you have revised the stability procedure to include accelerated and long-term stability testing.You indicated that you will conduct testing for the active ingredient and other specifications to support the (b)(4) expiration date.
在你们的回复中，你们声称你们修订了稳定性程序，在其中加入了加速和长期稳定性试验。你们说你们会对活性成分和其它质量标准进行测试用以支持XX有效期。
Your response is inadequate because it lacked athorough assessment of your stability program. You did not provide all the test specifications for stability and you did not commit to test reserve samples to support the expiry date of the distributed products.
你们的回复是不充分的，因为没有对你们稳定性计划进行彻底评估。你们并未提交所有稳定性检测标准，没有承诺对留样进行检测用以支持已销售产品的有效期。
In response to this letter, provide the following:
在回复本函时请提交以下资料：
• A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
• 一份全面独立的评估和CAPA计划，确保你们稳定性计划的充分性。你们的补救计划应包括但不仅限于：
Stability indicating methods
稳定性指示性方法
Stability studies for each drug product in its marketed container-closure system before distribution is permitted
在允许上市销售之前，对每个药品以上市包装形式进行稳定性研究
An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid
每年增加每个产品代表批次进行持续稳定性研究，以确保货架期声明是否持续有效
Detailed definition of the specific attributes to be tested at each station (timepoint)
在每个时间点要检测的项目的详细规定
• All procedures that describe these and other elements of your remediated stability program.
• 说明这些和你们已补救稳定性计划其它要素的所有程序
Data Integrity Remediation 数据完整性补救
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 FDAs guidance documentData Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.
你们的质量体系不足以确保支持你们所生产药品安全性、有效性和质量的数据的准确性和完整性。参见FDA指南文件“数据完整性和药品CGMP合规”。
We strongly recommend that you retain a qualifiedconsultant to assist in your remediation.
我们强烈建议你们聘请一位具备资质的顾问来协助你们进行补救。
In response to this letter, provide the following:
在回复本函时请提交以下资料：
• A comprehensive investigation into the extent ofthe inaccuracies in data records and reporting including results of the datareview 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，包括销售至开卷有益国的药品的数据审核结果。还要提交一份对你们数据完整性问题范围和根本原因的详细说明
• 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。
• 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所有数据（包括微生物和分析数据、生产记录和所有提交给FDA的数据）的可靠性和完整性
CGMP Consultant Recommended CGMP顾问建议
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting drug CGMP requirements.
鉴于我们在你公司所发现的违规情况，我们强烈建议你们使用一位有21 CFR 211.34所述资质的顾问来协助你们公司符合CGMP要求。
Your use of a consultant does not relieve your firms obligation to comply with CGMP. Your firms executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
你们使用顾问并不能解除你们公司符合CGMP的义务。你们公司的高级管理层仍负有义务全面解决所有缺陷，确保持续CGMP符合性。
Conclusion 结论
The violations cited in this letter are notintended to be an all-inclusive list of violations that exist at your facility in connection with your product. 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。
FDA placed your firm on Import Alert 66-40 on June18, 2020.
FDA已于2020年6月18日将你公司置于进口禁令66-40中。
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商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 PT. MegaSurya Mas, J1 Tambak Sawah 32, Sidoarjo 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 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.
Please identify your response with FEI 3007801999and ATTN: Chhaya Shetty.
Sincerely,
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
文章来源：法默康GMP咨询
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