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12月10日，F(xiàn)DA發(fā)布了對Guangzhou Four E’s Scientific Co., Ltd.的警告信，警告信中披露了該公司的無菌產(chǎn)品，由CMO生產(chǎn)，F(xiàn)DA檢查了該公司提供的來自CMO的質(zhì)量標(biāo)準(zhǔn)發(fā)現(xiàn)，檢驗(yàn)的是需氧菌總數(shù)，檢驗(yàn)標(biāo)準(zhǔn)為“≤xx”。FDA表示：無菌產(chǎn)品必須符合USP <71>，無菌檢查，應(yīng)無活的微生物。

 

此外，還發(fā)現(xiàn)該CMO存在原輔料檢驗(yàn)不充分、工藝驗(yàn)證不完整和成品檢驗(yàn)不充分等GMP違規(guī)。

 

警告信翻譯如下：

 

November 13, 2024

 

Dear Mr. Wan:

 

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 4, 2024 request, and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Guangzhou Four E’s Scientific Co. Ltd., FEI 3009155756, at 5th Floor, Building C, No. 2 Ruitai Road, Huangpu District, Guangzhou, Guangdong 510700, China.

 

你們工廠在FDA注冊為非處方藥生產(chǎn)商。FDA已經(jīng)審核了你們根據(jù)FD&C法案第704(a)(4)條提交的關(guān)于你們工廠的記錄和其他信息的記錄，該工廠位于廣州黃浦區(qū)瑞泰路2號C棟5樓，F(xiàn)EI 3009155756，中國廣東廣州510700。

 

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).

 

本警告信總結(jié)了成品藥品嚴(yán)重違反現(xiàn)行良好生產(chǎn)規(guī)范（CGMP）規(guī)定的情況。參見21 CFR, parts 210 and 211。

 

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs described in your response to our 704(a)(4) request 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)).

 

由于你們對我們704(a)(4)要求的回復(fù)中所描述的藥品生產(chǎn)、加工、包裝或保存的方法、設(shè)施或控制不符合CGMP，根據(jù)FD&C法案第501(a)(2)(B)條(21 U.S.C. 351(a)（2)(B)），你們的藥品被認(rèn)定為摻假。

 

Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:

 

在對根據(jù)FD&C法案第704(a)(4)條提供的記錄和其他信息進(jìn)行審查后，發(fā)現(xiàn)重大違規(guī)行為包括但不限于以下：

 

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).

 

貴公司的質(zhì)量控制部門未能履行其職責(zé)，以確保所生產(chǎn)的藥品符合CGMP，并符合既定的鑒定、劑量、質(zhì)量和純度標(biāo)準(zhǔn)（21 CFR 211.22）。

 

Your quality unit (QU) failed to have adequate oversight and procedures for your contract manufacturing organization (CMO) to ensure that they operate in compliance with CGMPs.

 

你們的質(zhì)量部門（QU）未能對你們的合同生產(chǎn)組織（CMO）有足夠的監(jiān)督和程序來確保他們的操作符合CGMP。

 

Your firm utilized a CMO,(b)(4), to perform manufacturing, processing, and packaging activities on your behalf. You received drug products from this CMO and declared your firm as the manufacturer on import records.

 

你們公司利用CMO （xx）代表你們執(zhí)行生產(chǎn)、加工和包裝活動。你們從該CMO收到藥品，并在進(jìn)口記錄中申報(bào)你們公司為生產(chǎn)商。

 

The records and information you provided demonstrate that your firm did not effectively exercise its CGMP responsibilities. Specifically, your firm’s QU failed to ensure that all drug products produced for your firm possessed appropriate quality attributes. For example, your quality agreement indicates that you establish your quality requirements and your CMO must satisfy the quality requirements. Your product is labeled as sterile. However, in your response dated March 18, 2024, you submitted specifications from your CMO for your(b)(4) product labeled as sterile, showing microbiological testing with specifications of “≤(b)(4)” for aerobic plate count.1 Sterile products introduced to the U.S. market must meet United States Pharmacopeia (USP) <71>, Sterility Tests, to be free from viable microorganisms.

 

你們提供的記錄和信息證明貴公司沒有有效地履行CGMP責(zé)任。具體來說，貴公司的質(zhì)量部門（QU）未能確保為你們公司生產(chǎn)的所有藥品都具有適當(dāng)?shù)馁|(zhì)量屬性。例如，你們的質(zhì)量協(xié)議表明你們建立了質(zhì)量要求，你們的CMO必須滿足這些質(zhì)量要求。你們的產(chǎn)品標(biāo)簽上聲明無菌。然而，在你們2024年3月18日的回復(fù)中，你們提交了你們CMO標(biāo)注無菌的xx產(chǎn)品的標(biāo)準(zhǔn)，顯示需氧菌總數(shù)的微生物檢測標(biāo)準(zhǔn)為“≤xx”。銷往美國市場的無菌產(chǎn)品必須符合美國藥典(USP) <71>，無菌檢查，應(yīng)無活的微生物。

 

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

 

此外，藥品必須按照CGMP生產(chǎn)。FDA意識到許多藥品制造商使用獨(dú)立的承包商，如生產(chǎn)設(shè)施、測試實(shí)驗(yàn)室、包裝商和貼標(biāo)商。FDA將承包商視為制造商的延伸。

 

A 704(a)(4) records review of your CMO,(b)(4), found significant violations of CGMP including, but not limited to, inadequate testing of raw materials, incomplete process validation and inadequate testing of finished products. These CGMP violations render the products manufactured by (b)(4) adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. FDA placed products offered for import to the United States from (b)(4) on Import Alert (b)(4), on (b)(4), and issued Warning Letter (b)(4) on (b)(4).

 

對你們CMO的704(A)(4)記錄審核發(fā)現(xiàn)了重大的CGMP違規(guī)行為，包括但不限于原輔料檢驗(yàn)不充分、工藝驗(yàn)證不完整和成品檢驗(yàn)不充分。這些CGMP違規(guī)行為使得(b)(4)生產(chǎn)的產(chǎn)品在FD&C法案第501(a)(2)(b)條的意義上認(rèn)定為摻假。FDA將提供從(b)(4)進(jìn)口到美國的產(chǎn)品置于(b)(4)上的進(jìn)口警報(bào)(b)(4)上，并發(fā)出警告信。

 

You, including your QU, are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov>media>download.

 

你們，包括你們的質(zhì)量部門，要對你們藥品的質(zhì)量負(fù)責(zé)，不管你們是否與你們的合同工廠達(dá)成了協(xié)議。你們必須確保藥品是按照FD&C法案501(a)(2)(B)條款生產(chǎn)的，以確保安全性、鑒別、劑量、質(zhì)量和純度。見FDA指南《藥品合同生產(chǎn)安排：質(zhì)量協(xié)議》，網(wǎng)址：https://www.fda.gov>media>download。

 

See FDA’s guidance documentQuality 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.

 

參見FDA指南《藥品CGMP法規(guī)質(zhì)量體系方法》，以幫助實(shí)施質(zhì)量體系和風(fēng)險(xiǎn)管理方法，以滿足CGMP法規(guī)21 CFR，第210部分和211部分的要求，網(wǎng)址為https://www.fda.gov/media/71023/download。

 

In response to this letter, provide:

 

回復(fù)此函，請?zhí)峁?/span>

 

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:

 

一個全面的評估和補(bǔ)救計(jì)劃，以確保你們的QU獲得有效運(yùn)作的權(quán)限和資源。評估還應(yīng)包括但不限于:

 

A determination of whether procedures used by your firm are robust and appropriate.

 

確定貴公司所使用的程序是否健全和適當(dāng)。

 

Provisions for QU oversight throughout your operations, including an evaluation of your contract manufacturer qualification program, to evaluate adherence to appropriate practices.

 

在你們的整個運(yùn)營過程中規(guī)定QU監(jiān)督，包括對你們的合同制造商確認(rèn)程序的評估，以評估對適當(dāng)實(shí)踐的遵守情況。

 

A complete and final review of each batch and its related information before the QU disposition decision.

 

在作出處置決定前，對每個批次及其相關(guān)信息進(jìn)行完整和最終的審查。

 

Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

 

監(jiān)督和批準(zhǔn)調(diào)查并履行所有其他質(zhì)檢職責(zé)，以確保所有產(chǎn)品的鑒定、劑量、質(zhì)量和純度。

 

A complete evaluation of drug product specifications for the (b)(4) to determine whether the specifications are appropriate.

 

對藥品說明書進(jìn)行完整的評價(jià)，以確定說明書是否合適。