中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

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品，由CMO生產，F(xiàn)DA檢查了該公司提供的來自CMO的質量標準發(fā)現(xiàn)，檢驗的是需氧菌總數(shù)，檢驗標準為“≤xx”。FDA表示：無菌產品必須符合USP <71>，無菌檢查，應無活的微生物。

 

此外，還發(fā)現(xiàn)該CMO存在原輔料檢驗不充分、工藝驗證不完整和成品檢驗不充分等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商。FDA已經審核了你們根據(jù)FD&C法案第704(a)(4)條提交的關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).

 

本警告信總結了成品藥品嚴重違反現(xiàn)行良好生產規(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)要求的回復中所描述的藥品生產、加工、包裝或保存的方法、設施或控制不符合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).

 

貴公司的質量控制部門未能履行其職責，以確保所生產的藥品符合CGMP，并符合既定的鑒定、劑量、質量和純度標準（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.

 

你們的質量部門（QU）未能對你們的合同生產組織（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、加工和包裝活動。你們從該CMO收到藥品，并在進口記錄中申報你們公司為生產商。

 

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責任。具體來說，貴公司的質量部門（QU）未能確保為你們公司生產的所有藥品都具有適當?shù)馁|量屬性。例如，你們的質量協(xié)議表明你們建立了質量要求，你們的CMO必須滿足這些質量要求。你們的產品標簽上聲明無菌。然而，在你們2024年3月18日的回復中，你們提交了你們CMO標注無菌的xx產品的標準，顯示需氧菌總數(shù)的微生物檢測標準為“≤xx”。銷往美國市場的無菌產品必須符合美國藥典(USP) <71>，無菌檢查，應無活的微生物。

 

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。FDA意識到許多藥品制造商使用獨立的承包商，如生產設施、測試實驗室、包裝商和貼標商。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不充分、工藝驗證不完整和成品檢驗不充分。這些CGMP違規(guī)行為使得(b)(4)生產的產品在FD&C法案第501(a)(2)(b)條的意義上認定為摻假。FDA將提供從(b)(4)進口到美國的產品置于(b)(4)上的進口警報(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，包括你們的質量部門，要對你們藥品的質量負責，不管你們是否與你們的合同工廠達成了協(xié)議。你們必須確保藥品是按照FD&C法案501(a)(2)(B)條款生產的，以確保安全性、鑒別、劑量、質量和純度。見FDA指南《藥品合同生產安排：質量協(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)質量體系方法》，以幫助實施質量體系和風險管理方法，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救計劃，以確保你們的QU獲得有效運作的權限和資源。評估還應包括但不限于:

 

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。

 

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

 

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

 

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信息進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)督和批準調查并履行所有其他質檢職責，以確保所有產品的鑒定、劑量、質量和純度。

 

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

 

對藥品說明書進行完整的評價，以確定說明書是否合適。