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行業新聞

【FDA警告信】韓國Dae Young Foods Company, Ltd.

2017-11-29 Julia GMP行業新聞

近日,美國FDA發布了關于韓國Dae Young Foods Company, Ltd.的警告信,FDA于2017年3月13日至17日對該公司進行了檢查,發現其制劑生產存在嚴重違反CGMP的行為。


具體缺陷如下:


1.    Your firm failed to visuallyexamine each container of components for appropriate labeling as to contentsupon receipt and before acceptance (21 CFR 211.82(a)).

 你們公司沒有在接收和放行之前對每個成分容器目視檢查其標簽是否恰當(21 CFR 211.82(a))。


Your firm accepted at least one shipment of a drugcomponent without ensuring it was properly labeled. For example, the label ondrums of an in-process (b)(4) #(b)(4) containing multiple activeingredients indicated “(b)(4)” only and failed to identify any of theactive ingredients in the component or list their concentrations. Furthermore,the batch number on the drums did not match the batch number in the documentsyou provided to support the use of this component.

 你們公司接受了一種藥品成分的至少一次運送批,而沒有確保其有適當的標簽。例如,一個中間體XX中包含有多個活性成分,桶上的標簽只顯示了XX,而沒有標識出其中的任何活性成分,也未列出其對應濃度。另外,桶上的批號與你們所提供的用以支持使用此成分的文件中所列的批號不符。


This in-process (b)(4) was manufactured fromingredients that pose potentially toxic effects, such as (b)(4),which contains (b)(4). You manufactured a homeopathic drug product, (b)(4),using a portion of the component that you accepted without examining forappropriate labeling. 

此中間體是采用具有潛在毒性效果的成分所生產的,例如 XX,其中含有YY。你們生產一種順勢療法藥品ZZ,使用了此成分的一總分,而你們在接受該成分時并沒有檢查其標簽是否適當。


You cannot accept drug components unless thecontainers are appropriately labeled as to contents. In response to thisletter provide your detailed plan for ensuring that incoming drug componentsyou receive from your suppliers are appropriately labeled as to contents, forexample, accurately labeled with the identity and strength of all ingredients.

 如果容器標簽未依據其內容物進行適當標示,你們是不能接受該藥品成分的。在回復此函時,請提交你們的詳細計劃,確保你們從你們供應商處接受的進廠藥品成分按其內容物進行了適當標示,例如,準確標明其成分和所有成分的含量。


2.   Your firm failed to conduct at leastone test to verify the identity of each component of a drug product. Your firmalso failed to test each component for conformity with all appropriate writtenspecifications for purity, strength, and quality (21 CFR 211.84(d)(1) &(2)).

 你們公司未能實施至少一項檢測來核查藥品的每種成分的鑒別。你們公司也沒有對每種成分進行檢查,確認其符合所有適當的書面純度、含量和質量標準(21 CFR 211.84(d)(1) & (2))。


Your firm failed to test incoming drug components, thein-process (b)(4) received from (b)(4), for identity or anyquality criteria prior to use in your drug manufacturing process. By notadequately analyzing these in-process (b)(4) for identity, purity,strength, and quality, you failed to ensure the suitability of incoming rawmaterials for processing.

 你們公司在藥品生產前,未對所用進廠藥品成分,從XX接受的中間體,檢測其鑒別或任何的質量標準。由于未能對這些中間體的鑒別、純度、含量和質量進行充分的分析檢測,你們無法確保用于工藝生產的進廠原料的適用性。


Your firm also has not established the reliability ofyour in-process (b)(4) supplier’s certificates of analysis. Your use ofsupplier questionnaires, without appropriate validation of your supplier’s testresults, is inadequate to ensure the certificates of analysis you receive canbe used in lieu of testing your drug components for quality attributes.

 你們公司亦未建立你們中間體XX供應商的COA的可靠性。你們使用了供應商問卷,而沒有對你們供應商的檢測結果進行適當的驗證,這樣無法確保你們所收到的COA可以用于替代你們對藥品成分的質量屬性的檢測。


In your response, you stated that you will begintesting your incoming in-process (b)(4) for the presence of (b)(4),but not the active ingredients in this (b)(4). The active ingredientsyou purport to use are potentially toxic and could pose a significant safetyhazard if present in levels higher than the labeled content. 

在你們的回復中,你們聲稱你們要開始檢測你們的進廠中間體中XX是否存在,而不檢測其中的活性成分。你們所使用的該活性成分具有潛在毒性,如果其含量水平高于其標示含量,可能具有重大的安全危害性。


3.    Your firm failed to establish anadequate quality control unit and procedures applicable to the quality controlunit with the responsibility and authority to approve or reject all components,drug product containers, closures, in-process materials, packaging materials,labeling, and drug products (21 CFR 211.22(a) and (d)).

 你們公司未建立足夠的質量部門和程序,使得質量部門具備職責和權力來批準或拒收所有成分、藥品容器、密閉器、中間物料、包裝物料、標簽和藥品(21 CFR 211.22(a) and (d))。


Your firm lacks an adequate quality control unit.

 你們公司缺乏足夠的質量部門。


You failed to establish written procedures fornumerous functions. For example, there were no procedures addressing thequality control unit, complaints, deviations, investigations, and various otherbasic drug manufacturing operations.

 你們有許多的職能均未建立書面程序。例如,沒有關于質量部門、投訴、偏差處理、調查和其它不同基本藥品生產操作的程序。


Further, your quality unit lacked documentation todemonstrate acceptability of batch manufacturing and quality. For instance, youlacked records relating to:

另外,你們的質量部門缺乏文件記錄來證明批生產和質量的可接受性。例如,你們缺少以下相關記錄:

  • change control; 變更控制

  • annual product reviews; 年度產品回顧

  • batch record review to assure that any errors were discovered and     fully investigated; and 批記錄審核,以確保發現和全面調查所有錯誤,以及

  • approval or rejection of your drug products.  你們藥品的批準和拒收


Misbranded drug charge 冒牌藥品指控 


Your firm’s product, Smoker’s Appetite Relief is adrug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), becauseit is intended to diagnose, cure, mitigate, treat, or prevent disease, and/orintended to affect the structure or any function of the body. Examples ofclaims that establish the intended uses for Smoker’s Appetite Relief include,but may not be limited to, the following: 

你們公司的藥品,吸煙者食欲緩解產品依據FDCA第201(g)和21 U.S.C. 321(g)(1)定義是一種藥品,因為其因為其用于診斷、治療或預防疾病,和/或用于影響人體結構或功能。表明吸煙者食欲緩解產品既定用途的聲明內容包括但不僅限于以下:

  • Temporarily relieves and calms 暫時緩解和鎮定

o   Excessive Appetite 過量食欲

o   Food Cravings 食物渴望

o   Overeating 飲食過量

o   Irritability 易怒

  • The purposes of the ingredients are listed as 成分的目的列出如下:

o    Nicotine cleansing 尼古丁凈化

o    Excessive appetite, overeating 過量食欲,飲食過量

o    Food cravings食物渴望

o    Liver support 肝支持

o    Digestion / metabolism support 消化/代謝支持

o    Melancholy 憂郁

o    Mental withdrawal 心理戒斷

o    Physical withdrawal 物理戒斷

o    Irritability 易怒

Under section 502(a) of the FD&C Act, 21 U.S.C.352(a), a drug is misbranded if its labeling is false or misleading in anyparticular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), providesthat, “in determining whether [an article’s] labeling or advertising ismisleading there shall be taken into account . . . not only representationsmade or suggested . . . but also the extent to which the labeling oradvertising fails to reveal facts material in the light of suchrepresentations.” According to your batch record for Smoker’s Appetite Relief,there are numerous ingredients that were included in the product but were notdeclared on the finished product label, such as (b)(4), and (b)(4).In addition, there are ingredients listed on the finished product label that donot appear in the batch record, such as Carduus marianus, Hypericum, Kreosotum,and Lobelia. The failure to declare ingredients on the label and the inclusionof ingredients on the label that were not included in the product is false ormisleading, and therefore such product is misbranded under section 502(a) ofthe FD&C Act.

 依據FDCA第502(a)部分和21 U.S.C. 352(a)規定,一種藥品如果其標簽錯誤或者在任何方面有誤導,則該藥品即為冒牌藥品。FDCA第201(n)和21 U.S.C. 321(n)規定“在確定一個產品的標簽或廣告是否具有誤導性時,應考慮……不僅……所呈現或建議的……還有標簽或廣告在此類呈現中未能揭示的實際材料的程度。”依據你們的吸煙者食欲緩解產品的批記錄,產品中含有大量的成分,但在成品標簽上并未寫明。例如XX和YY。此外,列在成品標簽上的成分則并未出現在批記錄中,如水飛薊、金絲桃、木焦油以及半邊蓮。未能在標簽上寫明成分,以及標簽所指成分實際在產品中并不包括是造假或誤導,因此此類產品依據FDCA第502(a)部分被認為是冒牌藥品。


We recognize that Smoker’s Appetite Relief is labeled asa homeopathic drug with active ingredients measured in homeopathic strengths.Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term“drug” includes articles recognized in the official Homeopathic Pharmacopeia ofthe United States (HPUS), or any supplement to it. Homeopathic drugs aresubject to the same regulatory requirements as other drugs; nothing in theFD&C Act exempts homeopathic drugs from any of the requirements related toadulteration, labeling, misbranding, or approval. We acknowledge that manyhomeopathic drugs are manufactured and distributed without FDA approval underenforcement policies set out in the FDA’s Compliance Policy Guideentitled, Conditions Under Which Homeopathic Drugs May be Marketed (CPG400.400) (the CPG). As its title suggests, the CPG identifies specificconditions under which homeopathic drugs may ordinarily be marketed; thus, inorder to fall under the enforcement policies set forth in the CPG, ahomeopathic product must meet the conditions set forth in the CPG.

 我們了解吸煙者食欲緩解產品標簽作為順勢療法藥品,其中含有活性成分按順勢療法劑量加入。依據FDCA第201(g)(1)部分和21 U.S.C. 321(g)(1),術語“藥品”包括在美國官方順勢療法藥典(HPUS)及其增補中所認可的產品。順勢療法藥品與其它藥品一樣受到相同的法規要求約束,FDCA中的條款在摻假、標簽、冒牌或批準方面對于順勢療法藥品并無任何豁免。我們知曉許多順勢療法藥品在沒有FDA批準情況下生產和銷售,不符合FDA符合性政策指南“順勢療法藥品可以上市銷售的條件(CPG 400.400)(CPG)”中設定的強制政策。正如其標題所要求,CPG說明了順勢療法藥品通常可以上市銷售的具體條件,因此,為了使產品符合CPG所設定的實施政策范圍,順勢療法藥品必須符合CGP中所設定的條件。


The introduction or delivery for introduction intointerstate commerce of a drug that is misbranded or adulterated violatessection 301(a) of the FD&C Act, 21 U.S.C. 331(a).

將冒牌或摻假藥品引入或發送進入州際貿易違反了FDCA第301(a)部分和21 U.S.C. 331(a)規定。


Responsibilities as a contractor 作為合同生產商的職責


Drugs must be manufactured in conformance with CGMP.FDA is aware that many drug manufacturers use independent contractors, such asproduction facilities, testing laboratories, packagers, and labelers. FDAregards contractors as extensions of the manufacturer.

藥品生產必須符合CGMP要求。FDA了解許多藥品生產商會使用獨立的合同生產商,如何生產設施、檢測實驗室、包裝商和標簽商。FDA認為這些合同生產商是生產商的延伸。

You and your customer, (b)(4), have a qualityagreement regarding the manufacture of (b)(4). You are responsiblefor the quality of drugs you produce as a contract facility, regardless of thequality agreements in place. You are required to ensure that drugs are made inaccordance with section 501(a)(2)(B) of the FD&C Act.  

你和你的客戶XX簽訂了關于XX生產的質量協議。作為合同場所,無論是否簽有質量協議,你們均對你們生產的藥品負有責任。你們需要確保你們按FDCA第501(a)(2)(B)部分生產藥品。

Refer to the FDA’s guidance for industry, ContractManufacturing Arrangements for Drugs: Quality Agreements, at https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf.

請參見FDA行業指南“藥品合同生產安排:質量協議”。


轉自:Julia法規翻譯


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