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前言
2025年2月18日，F(xiàn)DA發(fā)布了一篇在2025年2月6日給Tyche Industries Ltd的警告信。FDA在檢查中發(fā)現(xiàn)堤喀工業(yè)有限公司在藥品生產(chǎn)過程中存在嚴(yán)重的CGMP偏差，涉及數(shù)據(jù)完整性、設(shè)備清潔、物料鑒別和質(zhì)量單位職責(zé)履行等多個(gè)方面。以下是詳細(xì)介紹：
1、未能記錄所有質(zhì)量相關(guān)活動(dòng)：
公司管理層承認(rèn)存在偽造數(shù)據(jù)的行為，例如在生產(chǎn)過程中未開啟干燥箱的情況下偽造溫度數(shù)據(jù)。
生產(chǎn)、質(zhì)量保證和質(zhì)量控制部門的管理人員參與了“倒填日期計(jì)算表”的準(zhǔn)備工作，并將其交給調(diào)查人員。
公司的記錄實(shí)踐不符合CGMP要求。
2、設(shè)備清潔與維護(hù)不足：
FDA記錄了生產(chǎn)設(shè)備中存在鐵銹樣殘留物和裸露足跡，但設(shè)備標(biāo)簽顯示已清洗并準(zhǔn)備好使用。
公司未能提供有效的清潔程序，以防止污染或物料殘留。
公司未能充分解釋如何防止類似問題再次發(fā)生。
3、未能對(duì)進(jìn)廠生產(chǎn)物料進(jìn)行鑒別：
用于生產(chǎn)原料藥的進(jìn)廠物料未經(jīng)過充分的鑒別測(cè)試。
公司未能說明是否對(duì)所有原材料進(jìn)行了鑒別測(cè)試，以及如何防止新的原材料再次出現(xiàn)類似偏差。
4、質(zhì)量單位（QU）職責(zé)履行不充分：
QU未能確保CGMP記錄的完整性，未能對(duì)每一批次及其相關(guān)信息進(jìn)行完整和最終的審核。
QU未能有效監(jiān)督整個(gè)運(yùn)營(yíng)過程，確保對(duì)適當(dāng)實(shí)踐的遵守。
5、數(shù)據(jù)完整性問題：
公司的質(zhì)量體系未能確保數(shù)據(jù)的準(zhǔn)確性和完整性。
公司未能充分評(píng)估數(shù)據(jù)完整性問題的范圍，包括通過面談現(xiàn)任和前任員工以及全面審查數(shù)據(jù)記錄。
基礎(chǔ)信息
產(chǎn)品:Drugs
參考編號(hào):320-25-41
檢查日期：2024年8月12日至16日
收件人:Mr. Sandeep Gokaraju
警告信正文
Warning Letter320-25-41
February 6, 2025
Dear Mr. Gokaraju:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tyche Industries Ltd, FEI 3004790309, at 6-223, Sarpavaram (V), Kakinada, from August 12 to 16, 2024.
美國(guó)美國(guó)食品藥品監(jiān)督管理局(FDA)于2024年8月12日至16日檢查了您的藥品生產(chǎn)工廠——堤喀工業(yè)有限公司(FEI 3004790309 ),地址為:6-223，Sarpavaram (V), Kakinada。
This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).
這封警告信總結(jié)了活性藥物成分(原料藥)與現(xiàn)行良好生產(chǎn)規(guī)范(CGMP)的重大偏差。
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).
因?yàn)槟愕纳a(chǎn)、加工、包裝或保存的方法、設(shè)備或控制不符合CGMP，你的原料藥屬于《聯(lián)邦食品、藥品和化妝品法案》(FD&C法案)第501(a)(2)(B)節(jié)，21 U.S.C. 351(a)(2)(B)定義的摻假。
We reviewed your September 4, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
我們?cè)敿?xì)審查了您2024年9月4日對(duì)我們的FDA 483表格的回復(fù)，并確認(rèn)收到您隨后的信函。
During our inspection, our investigator observed specific deviations including, but not limited to, the following.
在我們的檢查過程中，我們的調(diào)查員觀察到具體的偏差，包括但不限于以下內(nèi)容。
1.Failure to record all quality-related activities at the time they are performed.
1.未能在執(zhí)行時(shí)記錄所有與質(zhì)量相關(guān)的活動(dòng)。
Your quality unit (QU) failed to ensure the integrity of CGMP records. For example, during the inspection, a member of your management stated that two of your operators admitted to falsifying temperature data for a drying oven that was not turned on during the manufacture of a(b)(4) batch, which later failed to meet the residual solvents specification. In addition, an Assistant Manager in Production, an Assistant Manager in Quality Assurance, and a Quality Control Manager admitted to participating in the preparation of a “backdated calculation sheet” that was given to our investigator.
你的質(zhì)量部門(QU)未能確保CGMP記錄的完整性。例如，在檢查過程中，貴公司管理層的一名成員表示，貴公司的兩名操作員承認(rèn)偽造了一個(gè)干燥箱的溫度數(shù)據(jù)，該干燥箱在(b)(4)批次的生產(chǎn)過程中沒有打開，后來不符合殘留溶劑質(zhì)量標(biāo)準(zhǔn)。此外，生產(chǎn)部門的一名助理經(jīng)理、質(zhì)量保證部門的一名助理經(jīng)理和質(zhì)量控制經(jīng)理承認(rèn)參與了“倒填日期計(jì)算表”的準(zhǔn)備工作，并將其交給了我們的調(diào)查人員。
Your documentation practices were not indicative of a facility that is in compliance with CGMP.
你們的記錄實(shí)踐表明你們的工廠并不符合CGMP。
Your response is inadequate. You state that you plan to hire a consultant to identify data integrity gaps and prepare and implement an action plan by June 30, 2025, approximately ten months from the conclusion of the inspection, which documented serious questionable data integrity practices. In addition, you state that you removed some of the employees involved in these incidents from CGMP-related activities, but you do not explain what was done to prevent the other employees involved in these activities from further data integrity deviations. Finally, you do not fully evaluate the scope of data integrity lapses at your firm, including by interviewing current and former employees and comprehensively reviewing data records.
你的回復(fù)是不充分的。您表示，您計(jì)劃聘請(qǐng)一名顧問來確認(rèn)數(shù)據(jù)完整性差距，并在2025年6月30日前制定和實(shí)施一項(xiàng)行動(dòng)計(jì)劃，大約是檢查結(jié)束后的十個(gè)月，而該檢查記錄了嚴(yán)重有問題的數(shù)據(jù)完整性問題。此外，您表示，您將這些事件中涉及的一些員工從CGMP相關(guān)活動(dòng)中除名，但您沒有解釋采取了什么措施來防止這些活動(dòng)中涉及的其他員工出現(xiàn)進(jìn)一步的數(shù)據(jù)完整性偏差。最后，您沒有充分評(píng)估貴公司數(shù)據(jù)完整性失誤的范圍，包括通過面談現(xiàn)任和前任員工以及全面審查數(shù)據(jù)記錄。
Significant findings in this letter indicate that your QU is not fully exercising its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA’s guidances:Q8(R2) Pharmaceutical Development at https://www.fda.gov/ media/71535/ download, Q9 Quality Risk Management at https://www.fda.gov/media/167721/download and Q10 Pharmaceutical Quality System at https://www.fda.gov/ media/71553/download.
這封信中的重要發(fā)現(xiàn)表明您的QU沒有完全行使其權(quán)力和/或職責(zé)。您的公司必須向QU提供適當(dāng)?shù)臋?quán)限和足夠的資源，以履行其職責(zé)并始終如一地確保藥品質(zhì)量。有關(guān)建立和維護(hù)符合CGMP的質(zhì)量體系的指南，請(qǐng)參見FDA指南:https:/ /www.fda.gov/media/71535/download,的Q8(R2)制藥開發(fā)，https://www.fda. gov/media/167721/download的Q9質(zhì)量風(fēng)險(xiǎn)管理和https://www.fda.gov/media /71553/download.的Q10制藥質(zhì)量體系。
In your response to this letter, provide:
在回復(fù)此信時(shí)，請(qǐng)?zhí)峁?
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:
一項(xiàng)全面的評(píng)估和補(bǔ)救計(jì)劃，以確保您的質(zhì)量單位（QU）被賦予足夠的權(quán)力和資源，能夠有效運(yùn)作。評(píng)估還應(yīng)包括但不限于以下內(nèi)容：
o A determination of whether procedures used by your firm are robust and appropriate.
對(duì)貴公司所采用程序的穩(wěn)健性和適宜性的評(píng)估。
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
QU監(jiān)督整個(gè)運(yùn)營(yíng)過程的規(guī)定，以評(píng)估對(duì)適當(dāng)實(shí)踐的遵守情況。
o A complete and final review of each batch and its related information before the QU disposition decision.
在QU做出放行決策之前，對(duì)每一批次及其相關(guān)信息進(jìn)行完整和最終的審核。
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
對(duì)調(diào)查的監(jiān)督和批準(zhǔn)，以及履行所有其他QU職責(zé)，以確保所有產(chǎn)品的鑒別、規(guī)格、質(zhì)量和純度。
A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
對(duì)整個(gè)制造和實(shí)驗(yàn)室操作中使用的文件記錄系統(tǒng)進(jìn)行全面評(píng)估，以確定記錄實(shí)踐中的不足之處。包括一份詳細(xì)的糾正措施和預(yù)防措施(CAPA)計(jì)劃，該計(jì)劃將全面修正貴公司的記錄實(shí)踐，以確保貴公司在整個(gè)運(yùn)營(yíng)過程中保留可歸屬的、清晰的、完整的、原始的、準(zhǔn)確的同步記錄。
2.Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications.
2.未能清洗設(shè)備和器具以防止污染或物料的殘留，而污染或殘留會(huì)改變?cè)纤幍馁|(zhì)量，使其超出官方或其他已確定的質(zhì)量標(biāo)準(zhǔn)。
FDA documented rust-like residues inside(b)(4) non-dedicated (b)(4) used in the production of (b)(4). In addition, FDA documented bare footprints inside another (b)(4) used in the production of (b)(4). Each (b)(4) was labeled that it had been cleaned and was ready for use.
美國(guó)食品和藥物管理局記錄了用于生產(chǎn)(b)(4)的非專用(b)(4)中的鐵銹樣殘留物。此外，F(xiàn)DA記錄了用于生產(chǎn)(b)(4)的另一個(gè)(b)(4)內(nèi)部的裸露足跡。每個(gè)(b)(4)都貼有標(biāo)簽，說明已經(jīng)清洗干凈，可以使用。
Inadequately cleaned and maintained manufacturing equipment can lead to potential cross- contamination that could compromise your API’s quality and safety.
不充分的清潔和維護(hù)生產(chǎn)設(shè)備會(huì)導(dǎo)致潛在的交叉污染，危及你的原料藥的質(zhì)量和安全。
Your response is inadequate. You state that you reviewed the quality of the products manufactured in the impacted equipment since February 2024, but you do not describe how you conducted this review, nor the reason you limited your review to this timeframe. In addition, you do not adequately explain how you will prevent the failure to clean equipment after personnel enter inside it from recurring. Finally, you state that personnel entering inside equipment should “wear cloth shoe cover after removing shoe,” but failing to wear suitable clothing, including appropriate footwear, poses an unacceptable risk to the product.
你的回復(fù)是不充分的。您表示，自2024年2月以來，您審查了受影響設(shè)備中生產(chǎn)的產(chǎn)品的質(zhì)量，但您沒有說明您是如何進(jìn)行審查的，也沒有說明您將審查限制在這一時(shí)間范圍內(nèi)的原因。此外，你沒有充分解釋你將如何防止人員進(jìn)入設(shè)備后無法清潔設(shè)備的情況再次發(fā)生。最后，您聲明進(jìn)入設(shè)備內(nèi)部的人員應(yīng)該“脫鞋后穿上布鞋套”，但是未能穿上合適的衣服，包括合適的鞋子，會(huì)給產(chǎn)品帶來不可接受的風(fēng)險(xiǎn)。
In your response to this letter, provide:
在回復(fù)此信時(shí)，請(qǐng)?zhí)峁?
Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.
您的CAPA計(jì)劃對(duì)設(shè)施和設(shè)備實(shí)施常規(guī)的、警惕的運(yùn)營(yíng)管理監(jiān)督。除其他事項(xiàng)外，該計(jì)劃應(yīng)確保及時(shí)發(fā)現(xiàn)設(shè)備/設(shè)施性能問題、有效執(zhí)行維修、遵守適當(dāng)?shù)念A(yù)防性維護(hù)計(jì)劃、及時(shí)對(duì)設(shè)備/設(shè)施基礎(chǔ)設(shè)施進(jìn)行技術(shù)升級(jí)，以及不斷完善的管理審評(píng)制度。
A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one product.
對(duì)您的清潔效果進(jìn)行全面、獨(dú)立的回顧性評(píng)估，以評(píng)估交叉污染危害的范圍。包括殘留物的識(shí)別，其他可能未被適當(dāng)清洗的生產(chǎn)設(shè)備，以及對(duì)交叉污染的產(chǎn)品是否已放行銷售的評(píng)估。評(píng)估應(yīng)確定清潔程序和實(shí)踐的任何不足之處，并涵蓋用于生產(chǎn)多種產(chǎn)品的每件生產(chǎn)設(shè)備。
Your CAPA plan, based on the retrospective assessment of your cleaning program, 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 for all products and equipment; and all other needed remediations.
您的CAPA計(jì)劃，基于對(duì)您的清潔計(jì)劃的回顧性評(píng)估，包括對(duì)您的清潔過程和實(shí)踐的適當(dāng)補(bǔ)救，以及完成時(shí)間表。為設(shè)備清洗的生命周期管理提供您的程序中的漏洞的詳細(xì)總結(jié)。描述清潔計(jì)劃的改進(jìn)，包括清潔效果的提高；改進(jìn)對(duì)所有產(chǎn)品和設(shè)備適當(dāng)清潔的持續(xù)驗(yàn)證；以及所有其他需要的補(bǔ)救措施。
3.Failure to test the identity of each batch of incoming production material.
3.未能對(duì)每批進(jìn)廠的生產(chǎn)物料進(jìn)行鑒別。
Your incoming raw material used to manufacture API intended for the U.S. market was not adequately tested. For example, you did not test the(b)(4) used as a raw material in the production of (b)(4) for identity.
用于生產(chǎn)美國(guó)市場(chǎng)原料藥的進(jìn)廠物料沒有經(jīng)過充分的測(cè)試。例如，沒有對(duì)在(b)(4)的生產(chǎn)中用作原料的(b)(4)進(jìn)行鑒別測(cè)試。
Your response is inadequate. You state that you “initiated the activity” to test(b)(4) for identity. However, you do not address whether all other raw materials are tested for identity or how you will prevent this deviation from recurring with new raw materials.
你的回答是不充分的。您聲明您“發(fā)起了活動(dòng)”來進(jìn)行(b)(4)的鑒別。但是，您沒有說明是否所有其他原材料都經(jīng)過了鑒別測(cè)試，或者您將如何防止新的原材料再次出現(xiàn)這種偏差。
In your response to this letter, provide:
在回復(fù)此信時(shí)，請(qǐng)?zhí)峁?
A comprehensive, independent review of your material system to determine whether all suppliers of raw materials, 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 raw materials, containers, and closures.
對(duì)您的物料系統(tǒng)進(jìn)行全面、獨(dú)立的審查，以確定所有原材料、容器和密封件的供應(yīng)商是否都是合格的，以及物料是否指定了適當(dāng)?shù)挠行诨驈?fù)驗(yàn)期。審查還應(yīng)確定來料控制是否足以防止使用不合適的原料、容器和密封件。
The chemical and microbiological quality control specifications you use to test and release each incoming batch of raw material for use in manufacturing.
化學(xué)和微生物質(zhì)量控制標(biāo)準(zhǔn)，用于測(cè)試和放行每批用于生產(chǎn)的原材料。
A description of how you will test each raw material batch for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificates of analysis (COAs) instead of testing each raw material batch for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s 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 raw material batch.
描述你將如何測(cè)試每一批原料是否符合所有適當(dāng)?shù)臉?biāo)準(zhǔn)，包括鑒別、規(guī)格、質(zhì)量和純度。如果您打算接受供應(yīng)商的分析證書(COAs)的任何結(jié)果，而不對(duì)每批原材料的規(guī)格、質(zhì)量和純度進(jìn)行測(cè)試，請(qǐng)說明您將如何通過初始驗(yàn)證和定期再驗(yàn)證來建立供應(yīng)商結(jié)果的可靠性。此外，還應(yīng)承諾對(duì)每批來料至少進(jìn)行一次特定的鑒別測(cè)試。
A summary of results obtained from testing all raw materials to evaluate the reliability of the COA from each raw material manufacturer. Include your standard operating procedure that describes this COA validation program.
從測(cè)試所有原材料獲得的結(jié)果的總結(jié)，以評(píng)估來自每個(gè)原材料制造商的COA的可靠性。包括描述此COA驗(yàn)證計(jì)劃的標(biāo)準(zhǔn)操作程序。
A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
您的計(jì)劃摘要，該計(jì)劃旨在對(duì)您生產(chǎn)的藥品進(jìn)行檢驗(yàn)的合同設(shè)施進(jìn)行認(rèn)證和監(jiān)督。
Data Integrity Remediation
數(shù)據(jù)完整性補(bǔ)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 FDA’s 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.
你的質(zhì)量體系沒有充分確保數(shù)據(jù)的準(zhǔn)確性和完整性，以支持你生產(chǎn)的藥物的安全性、有效性和質(zhì)量。請(qǐng)參閱FDA的指導(dǎo)文件《數(shù)據(jù)完整性和符合藥物CGMP 》,以獲取建立和遵循符合CGMP的數(shù)據(jù)完整性規(guī)范的指導(dǎo)，網(wǎng)址為https://www.fda.gov/media/119267/download.
We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:
我們強(qiáng)烈建議您聘請(qǐng)合格的顧問來幫助您進(jìn)行補(bǔ)救。作為對(duì)這封信的回復(fù)，請(qǐng)?zhí)峁?
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.
對(duì)數(shù)據(jù)記錄和報(bào)告的不準(zhǔn)確程度進(jìn)行全面調(diào)查，包括在美國(guó)銷售的藥物的數(shù)據(jù)審查結(jié)果。包括數(shù)據(jù)完整性問題的范圍和根本原因的詳細(xì)描述。
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.
對(duì)觀察到的失敗對(duì)藥品質(zhì)量的潛在影響的當(dāng)前風(fēng)險(xiǎn)評(píng)估。您的評(píng)估應(yīng)包括對(duì)由于數(shù)據(jù)完整性缺失而影響的藥物放行給患者帶來的風(fēng)險(xiǎn)的分析，以及對(duì)正在進(jìn)行的操作帶來的風(fēng)險(xiǎn)的分析。
A management strategy for your firm that includes the details of your global CAPA 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.
貴公司的管理戰(zhàn)略，包括全面的CAPA計(jì)劃的細(xì)節(jié)。詳細(xì)的糾正措施計(jì)劃應(yīng)描述您打算如何確保貴公司產(chǎn)生的所有數(shù)據(jù)的可靠性和完整性，包括微生物和分析數(shù)據(jù)、生產(chǎn)記錄以及提交給FDA的所有數(shù)據(jù)。
Conclusion
結(jié)論
The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.
這封信中引用的偏差并不是您工廠中存在的所有偏差的清單。您負(fù)責(zé)調(diào)查和確定任何偏差的原因，并負(fù)責(zé)防止其再次發(fā)生或其他偏差的發(fā)生。
FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on January 2, 2025.
FDA于2025年1月2日將貴公司提供進(jìn)口到美國(guó)的產(chǎn)品置于進(jìn)口警報(bào)66-40。
Correct any deviations promptly. 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 any deviations.
及時(shí)糾正任何偏差。FDA可能會(huì)拒絕批準(zhǔn)將貴公司列為藥品制造商的新申請(qǐng)或補(bǔ)充申請(qǐng)，直到任何偏差得到完全解決，并且我們確認(rèn)貴公司符合CGMP。我們可能會(huì)重新檢查，以確認(rèn)您已經(jīng)完成了對(duì)任何偏差的糾正措施。
Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Tyche Industries Ltd in Kakinada, 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).
根據(jù)《FD&C法案》第801(a)(3)節(jié),《美國(guó)法典》第21卷第381(a)(3)節(jié)，未能解決任何偏差還可能導(dǎo)致FDA繼續(xù)拒絕將堤喀工業(yè)有限公司生產(chǎn)的產(chǎn)品輸入美國(guó)。根據(jù)《FD&C法案》第501(a)(2)(B)節(jié),《美國(guó)法典》第21卷第351(a)(2)(B)節(jié)的含義，在此授權(quán)下的有摻假嫌疑的物品可能會(huì)被扣留或拒絕入境，因?yàn)槠渲圃熘惺褂玫姆椒ê涂刂拼胧┧坪醪环螩GMP。
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations 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.
這封信通知您我們的發(fā)現(xiàn)，并為您提供解決上述不足的機(jī)會(huì)。收到此信后，請(qǐng)?jiān)?5個(gè)工作日內(nèi)以書面形式回復(fù)本辦公室。請(qǐng)具體說明您為解決任何偏差并防止其再次發(fā)生所做的工作。作為對(duì)這封信的回復(fù)，您可以提供更多信息供我們考慮，因?yàn)槲覀儗⒗^續(xù)評(píng)估您的活動(dòng)和實(shí)踐。如果您不能在15個(gè)工作日內(nèi)完成糾正措施，請(qǐng)說明您延遲的原因和您的完成時(shí)間表。
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004790309 and ATTN: Russell Riley.
將您的電子回復(fù)發(fā)送到CDER-OC-OMQ-Communications@fda.hhs.gov。請(qǐng)?jiān)诨貜?fù)中注明FEI 3004790309和收件人:Russell Riley。
來源：懂藥弟
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