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嘉峪檢測網 2025-03-11 20:44
Regulatory compliance in the pharmaceutical and medical-device sectors is paramount for protecting public health. In the United States, the Food and Drug Administration (FDA) enforces laws and regulations to ensure that products meet stringent safety and efficacy standards. To achieve that goal, the FDA conducts inspection of manufacturing and distribution facilities. Authority for such activities derives from the Federal Food, Drug, and Cosmetic (FD&C) Act, particularly section 704, which grants the FDA broad powers to inspect facilities, records, and products.
制藥和醫療器械行業的法規符合性對于保護公眾健康至關重要。在美國，FDA執行法律和法規以確保產品符合嚴格的安全性和有效性標準。為了實現這一目標，FDA 對制造和分銷設施進行檢查。此類活動的授權來自FD&C法案，特別是第704 節，該法案授予 FDA 檢查設施、記錄和產品的廣泛權力。
The FDA’s guidance documentCircumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection outlines the behaviors and actions that can be deemed noncompliant during such inspections (1). The guidance clarifies what constitutes as obstruction of an inspection, helping manufacturers to avoid legal and regulatory repercussions. The document covers a breadth of scenarios, from preannounced inspections to refusals to permit entry, providing a clear framework for understanding FDA expectations.
FDA 的指導文件《構成延遲、阻礙、限制或拒絕藥品或器械檢查的情況》概述了在此類檢查期間可能被視為不合規的行為和行動（1）。該指南闡明了什么構成阻礙檢查，幫助制造商避免法律和監管影響。該文件涵蓋了從預先宣布的檢查到拒絕允許進入的廣泛場景，為理解FDA 的期望提供了一個清晰的框架。
Key Areas of Concern
主要關注領域
The FDA guidance document identifies several key areas in which facilities must exercise caution to maintain compliance. Such areas include delaying, denying, limiting, or refusing an inspection. Each action can have significant implications for a facility, potentially leading to severe penalties, including the classification of products as adulterated.
FDA 指南文件確定了工廠必須謹慎行事以保持合規性的幾個關鍵領域。這些領域包括延遲、阻礙、限制或拒絕檢查。每項作都可能對工廠產生重大影響，可能導致嚴厲的處罰，包括將產品歸類為摻假。
Delay of Inspections:Preapproval and prelicense inspections tend to be preannounced, as are inspections for foreign facilities. Although the FD&C Act does not mandate preannouncements, they are a common practice to facilitate the inspection process. The FDA usually contacts a facility beforehand to ensure the availability of relevant records and personnel. However, delays in scheduling such inspections can constitute noncompliance, especially if a facility’s management fails to agree on a start date without reasonable explanation.
檢查延遲：批準前和許可證前檢查往往是預先通知的，對國外設施的檢查也是如此。雖然FD&C 法案沒有強制要求預先通知，但這是促進檢查過程的常見做法。FDA通常會事先聯系工廠，以確保相關記錄和人員準備就緒。但是，延遲安排此類檢查可能構成不合規，特別是如果工廠管理層在沒有合理解釋的情況下未能就開始日期達成一致。
Consider a scenario in which a facility is notified of an upcoming preapproval inspection. The FDA attempts to schedule the inspection, but the facility’s management continually requests postponements without providing valid reasons. Eventually, the facility stops responding to FDA communications. In that case, the facility’s actions could be interpreted as a deliberate attempt to delay the inspection, potentially leading to regulatory action. A reasonable explanation, such as ongoing renovations that render a facility inaccessible or unsafe, would mitigate the situation only if properly communicated and documented.
考慮這樣一種情況：工廠收到即將進行的批準前檢查的通知。FDA 試圖安排檢查，但工廠的管理層不斷要求推遲檢查，而沒有提供正當理由。最終，該工廠停止回應 FDA 的通報。在這種情況下，該設施的行為可能會被解釋為故意延遲檢查，這可能會導致監管行動。合理的解釋，例如正在進行的翻修導致設施無法進入或不安全，只有在適當溝通和記錄的情況下才能緩解這種情況。
Delay During an Inspection:FDA investigators are authorized to inspect all areas of a facility that bear on whether drugs or devices are adulterated, misbranded, or otherwise in violation of the FD&C Act. Delays during an inspection can arise from restricted access to operational areas, unavailability of necessary personnel, or delays in providing documentation. Such actions can hinder the inspection process significantly.
檢查期間的延誤：FDA 檢查人員有權檢查設施中所有與藥品或器械是否摻假、貼錯標簽或其他違反 FD&C 法案有關要求。檢查期間的延誤可能是：進入操作區域受限、缺乏必要人員或延遲提供文件。此類操作會嚴重阻礙檢查過程。
During an unannounced inspection, for example, an FDA investigator requests access to a facility’s sterile manufacturing area. The facility’s management, however, insists that the investigator wait several hours before entering, citing ongoing cleaning. Upon investigation, it is revealed that no such cleaning was scheduled, and the delay was an attempt to prevent the investigator from observing specific production activities. Such behavior would be deemed noncompliant because it obstructs the investigator’s ability to conduct a thorough inspection.
例如，在突擊檢查期間，FDA 檢查人員要求進入工廠的無菌生產區域。然而，該設施的管理層堅持要求檢查人員等待幾個小時才能進入，理由是正在進行清潔。經調查，發現沒有安排此類清潔，此延遲是為了阻止檢查人員觀察特定的生產活動。這種行為將被視為不合規，因為它阻礙了檢查人員進行徹底檢查的能力。
Delay in Producing Records:Facilities must be prepared to provide all requested documentation in a timely manner. Delays in producing records, especially without a reasonable explanation, can be considered an attempt to obstruct the inspection. The FDA’s authority extends to both hardcopy and electronic records, and facilities must ensure that such documents are readily accessible.
延遲提供記錄： 工廠必須準備好及時提供所有要求的文件。延遲提供記錄，尤其是沒有合理解釋，可被視為試圖阻礙檢查。FDA 的權力涵蓋硬拷貝和電子記錄，設施必須確保此類文件易于訪問。
Consider a facility that maintains its financial and production records at an offsite location. During an inspection, the FDA requests specific records, but the facility’s management states that accessing those records will take several days. Such a delay, if not adequately justified, could be considered an obstruction. However, if the facility provides a clear explanation (such as the need to retrieve records from a remote archive) and works to minimize the delay, then it can avoid noncompliance issues.
試想一下：一個在異地位置維護其財務和生產記錄的設施。在檢查期間，FDA 要求提供特定記錄，但該設施的管理層表示，訪問這些記錄需要幾天時間。這種延誤，如果沒有充分的理由，可被視為一種阻礙。但是，如果工廠提供明確的解釋（例如需要從遠程存檔中檢索記錄）并努力最大限度地減少延遲，那么它可以避免不合規問題。
Denial of Inspection:The FDA’s guidance interprets denial broadly, including behavior that prevents an FDA representative from conducting or completing an inspection. This encompasses both active refusals and passive actions that obstruct inspections. Denial can include outright refusals to schedule or allow inspections, as well as misleading or deceptive actions that hinder the inspection process.
拒絕檢查：FDA 的指南對拒絕檢查進行了廣泛的解釋，包括阻止FDA 人員進行或完成檢查的行為。這包括主動拒絕和阻礙檢查的被動行動。拒絕包括公然拒絕安排或拒絕允許檢查，以及阻礙檢查過程的誤導性或欺騙性行為。
For example, facility management falsely claims that it has ceased all manufacturing operations when FDA investigators arrive for an unannounced inspection. Representatives state that the site is undergoing renovations, and no products are being produced. However, subsequent evidence reveals that the facility had active production lines and was attempting to avoid inspection. Such behavior constitutes a clear denial of inspection because it involves intentionally misleading investigators.
例如，當 FDA 檢查人員到達現場進行突擊檢查時，管理部門錯誤地聲稱已停止所有生產業務。表示：該場地正在進行翻新，沒有生產任何產品。然而，隨后的證據表明，該工廠的生產線正在運行，并試圖逃避檢查。這種行為明顯構成拒絕檢查，因為它涉及故意誤導檢查人員。
Limiting Inspection: Limiting an inspection involves restricting its scope or extent, such as blocking access to certain areas, restricting observation of specific processes, or withholding information. The FDA considers such actions to be potentially obstructive because they prevent comprehensive evaluation of the facility’s compliance with regulatory standards. Facilities must provide FDA investigators with reasonable access to all areas and processes relevant to the inspection. Limiting access without a valid reason can be interpreted as an attempt to conceal noncompliance. For example, ceasing production during an inspection without reasonable explanation can hinder the FDA’s ability to observe standard operating procedures (SOPs) and manufacturing practices in action.
限制檢查：限制檢查涉及限制其范圍或程度，例如阻止訪問某些區域、限制對特定過程的觀察或隱瞞信息。FDA 認為此類行動具有潛在的阻礙性，因為它們會阻止對工廠是否符合監管標準進行全面評估。企業必須為 FDA 檢查人員提供與檢查相關的所有區域和工藝的合理訪問權限。在沒有正當理由的情況下限制訪問可以解釋為試圖掩蓋不合規行為。例如，在檢查期間在沒有合理解釋的情況下停止生產可能會阻礙 FDA 觀察標準作程序（SOP）和生產實踐的能力。
Imagine that an FDA inspection team arrives at a facility to conduct a routine inspection. Upon arrival, the team is informed that all production activities have been halted temporarily for maintenance reasons. However, there is no evidence of maintenance work being conducted, and the shutdown appears to have been orchestrated to prevent the inspection team from observing certain processes. Such actions are likely to be viewed as limiting inspection, potentially leading to regulatory action.
想象一下，一個 FDA 檢查組到達工廠進行例行檢查。到達后，團隊被告知，由于維護原因，所有生產活動都已暫時停止。然而，沒有證據表明正在進行維護工作，而且關閉似乎是經過精心策劃的，以防止檢查小組觀察某些過程。此類行動可能被視為限制檢查，并可能導致監管行動。
Limiting Photography: Photography during inspections serves as an objective method of documenting facility conditions. The FDA uses photographs to record evidence of compliance or noncompliance, such as the presence of contaminants, inadequate storage conditions, or improper labeling. Limiting the use of photography without legitimate reason can be seen as an attempt to obstruct the inspection.
限制拍照：檢查期間的拍照是記錄設施狀況的客觀方法。FDA 使用照片來記錄合規或不合規的證據，例如存在污染物、儲存條件不足或標簽不當。在沒有正當理由的情況下限制使用拍照可被視為企圖阻礙檢查。
During an inspection, for example, an FDA investigator attempts to photograph a specific area where raw materials are stored. The facility’s management objects, citing concerns about protecting trade secrets and proprietary processes. Although protecting sensitive information is a valid concern, it must be balanced against the need for transparency. The manufacturer should provide a reasonable explanation and offer alternate methods to document conditions without compromising proprietary information.
例如，在檢查期間，FDA 檢查人員試圖拍攝儲存原輔料的特定區域。該設施的管理層以對保護商業秘密和專有工藝的擔憂為由提出反對意見。盡管保護敏感信息是一個合理的擔憂，但它必須與透明度的需求相平衡。制造商應提供合理的解釋，并提供其他不會影響專有信息的方法來記錄情況。
Limiting Access to Records:The FDA’s ability to review and copy records is a critical component of its inspection process. Limiting access to records, redacting essential information, or providing incomplete documentation can hinder assessment. Facilities must ensure that all relevant records — including electronic data — are available and accessible to facilitate thorough inspection.
限制對記錄的訪問：FDA 審查和復制記錄的權利是其檢查過程的關鍵組成部分。限制對記錄的訪問、篡改重要信息或提供不完整的文件可能會阻礙檢查。企業必須確保所有相關記錄（包括電子數據）都可用且可訪問，以便于徹底檢查。
For instance, an FDA investigator might request access to production records, including batch records and quality-control (QC) data. The facility provides some documents but withholds others, claiming that they are not relevant to the inspection. However, upon review, it becomes evident that the withheld records contain critical information about product quality and safety. Such selective disclosure can be considered an attempt to limit inspection, potentially leading to significant regulatory consequences.
例如，FDA 檢查人員可能會請求訪問生產記錄，包括批記錄和質量控制 （QC） 數據。該設施提供了一些文件，但扣留了另外一些文件，聲稱這些文件與檢查無關。但是，經過審核，很明顯，被扣留的記錄包含有關產品質量和安全的關鍵信息。這種選擇性披露可被視為試圖限制檢查，可能導致重大的監管后果。
Limiting or Preventing Sample Collection: An integral part of FDA inspections, sample collection enables laboratory analysis and compliance verification. Preventing or limiting collection can disrupt an inspection and raise concerns about product integrity.
限制或阻止樣品采集：樣品采集是 FDA 檢查的一個組成部分，可用于實驗室分析和合規性驗證。阻止或限制收集可能會干擾檢驗并引起對產品完整性的擔憂。
During an inspection, for example, FDA investigators request samples of a recently manufactured batch of drug product (DP). The facility’s management refuses, citing that the samples are reserved for internal testing and cannot be released. The refusal to provide samples without a valid reason can be seen as an attempt to prevent the agency from conducting a thorough analysis. Facilities must ensure that all sample requests are met to verify product compliance.
例如，在檢查期間，FDA 檢查人員要求提供最近生產的藥品批次的樣品。該工廠的管理層拒絕，理由是這些樣品是留作內部檢測的，不能放行。在沒有正當理由的情況下拒絕提供樣品可以被視為試圖阻止FDA進行徹底分析。工廠必須確保滿足所有樣品請求，以驗證產品合規性。
Refusal to permit entry or inspection encompasses both active and passive behaviors that prevent FDA investigators from accessing a facility. This includes not unlocking doors, ignoring FDA communications, or otherwise making it difficult for investigators to conduct their work. Such actions can lead to severe regulatory consequences, including the classification of products as adulterated.
拒絕允許進入或檢查：包括主動和被動阻止 FDA 檢查人員進入設施的行為。這包括鎖門、無視 FDA 的溝通或以其他方式使檢查人員難以開展工作。此類行為可能導致嚴重的監管后果，包括將產品歸類為摻假商品。
Imagine that an FDA inspection team attempts to schedule an inspection with a facility but receives no response despite multiple attempts. When the team arrive at the facility, they find it locked with no staff available to grant entry. The lack of communication and refusal to permit entry can be considered an obstruction of the inspection process. The facility must ensure that appropriate personnel are available to facilitate the inspection and provide necessary access. Acceptable reasons for postponing FDA inspections include emergencies and natural disasters, renovations and other planned shutdowns, cybersecurity incidents, and absence of key personnel.
想象一下，FDA 檢查組試圖安排與工廠進行檢查，但盡管多次嘗試仍未收到任何回復。當團隊到達工廠時，他們發現設施上鎖著，沒有工作人員可以允許進入。缺乏溝通和拒絕允許進入可被視為對檢查過程的阻礙。設施必須確保有適當的人員來協助檢查并提供必要的通道。推遲FDA 檢查的可接受原因包括緊急情況和自然災害、裝修和其他計劃性關閉、網絡安全事件以及關鍵人員不可用。
Natural Disasters or Emergency Situations:During events such as the COVID-19 pandemic, companies faced significant disruptions that affected their ability to comply with inspection schedules. Natural disasters (e.g., hurricanes, floods, and earthquakes) also can render facilities temporarily inoperable or unsafe, justifying a request for inspection postponement.
自然災害或緊急情況： 在大流行等事件期間，公司面臨重大中斷，影響了他們遵守檢查計劃的能力。自然災害（例如颶風、洪水和地震）也可能導致設施暫時無法運行或不安全，因此有理由要求推遲檢查。
Planned Shutdowns or Renovations:If a company already has scheduled a shutdown for maintenance or renovations, and the FDA proposes an inspection date during that period, then the shutdown could be a legitimate reason to request a delay. The FDA itself acknowledges that such planned events, which temporarily disrupt normal operations, may not be considered inspection delays.
計劃性停工或翻新：如果一家公司已經安排停工進行維護或翻新，然后 FDA 建議在此期間進行檢查，那么停工可能是要求延遲的合法理由。FDA 本身承認，此類暫時擾亂正常運營的計劃事件可能不被視為檢查延誤。
Cybersecurity Incidents:In rare cases, companies can experience cybersecurity incidents that compromise their operational capabilities. For example, consider a company that experienced a significant cyberattack, leading to postponement of an FDA inspection by about a month. Although such situations typically are not publicized, they provide valid ground for requesting delays, especially when incidents affect access to critical systems or data.
網絡安全事件：在極少數情況下，公司可能會遇到損害其運營能力的網絡安全事件。例如，考慮一家公司遭受了一次重大網絡攻擊，導致FDA 檢查推遲了大約一個月。盡管此類情況通常不會公開，但它們為請求延遲提供了正當理由，尤其是當事件影響對關鍵系統或數據的訪問時。
Key Personnel Unavailability:Key staff members, such as those responsible for compliance or production, may become unexpectedly unavailable (e.g., due to illness or urgent personal matters). That could justify a request to postpone inspection. FDA guidance suggests that unavailability of essential personnel can be a reasonable explanation, especially if their presence is critical to inspection.
關鍵人員不可用： 關鍵員工（例如負責合規或生產的人員）可能會意外不可用（例如，由于疾病或緊急個人事務）。這可能證明推遲檢查的請求是合理的。FDA 指南表明，沒有必要人員可能是一個合理的解釋，特別是如果他們的存在對檢查至關重要。
Practical Implications and Best Practices
實際意義和最佳實踐
Understanding and adhering to FDA guidelines during inspections is crucial for maintaining compliance and avoiding severe penalties. Facilities must implement best practices to ensure that they are prepared for inspections and can respond appropriately to FDA requests. Below are some practical steps that facilities can take to maintain compliance during inspections.
在檢查過程中了解并遵守 FDA指南對于保持合規性和避免嚴厲處罰至關重要。企業必須實施最佳實踐，以確保他們為檢查做好準備，并能夠適當地響應 FDA的要求。以下是工廠可以采取的一些實際步驟，以便在檢查期間保持合規性。
Preinspection Preparation: Facilities should conduct regular training sessions for staff members to ensure that they are aware of the FDA’s inspection process and the facility’s compliance obligations. That includes training on proper documentation, record-keeping practices, and communication protocols during inspections.
檢查前準備：企業應定期為員工舉辦培訓課程，以確保他們了解 FDA 的檢查流程和企業的合規義務。這包括檢查期間有關正確文件、記錄保存實踐和溝通方案的培訓。
Maintaining accurate and up-to-date recordsis critical for demonstrating compliance. Facilities should establish robust record-keeping systems that provide easy retrieval of documents during inspections. This includes electronic record systems that are secure, reliable, and accessible to authorized personnel.
維護準確和最新的記錄對于證明合規性至關重要。工廠應建立強大的記錄保存系統，以便在檢查期間輕松檢索文件。這包括安全、可靠且可供授權人員訪問的電子記錄系統。
Facilities should conductregular internal audits to assess their compliance status and identify potential areas of concern. These audits can help facilities prepare for inspections by ensuring that all areas comply with FDA regulations and that all necessary documentation is readily available.
工廠應定期進行內部審計，以評估其合規性狀態并確定潛在的關注領域。這些審核可以通過確保所有區域都符合FDA 法規并且所有必要的文件都隨時可用，幫助工廠為檢查做好準備。
Facilities must provide FDA investigators withunrestricted access to all areas and processes relevant to the inspection. That also includes access to secure areas such as cleanrooms or sterile processing zones, following appropriate gowning and safety procedures.
企業必須允許 FDA 檢查人員不受限制地進入與檢查相關的所有區域和流程。這還包括進入安全區域，如潔凈室或無菌加工區，遵循適當的更衣和安全程序。
Transparencyis key during inspections. Facilities should provide complete, accurate information to FDA investigators and prevent any actions that could be perceived as obstructive. Delays and restrictions must have clear explanations, and information and sample requests still must be met.
透明度是檢查過程中的關鍵。企業應向 FDA 人員提供完整、準確的信息，并防止采取任何可能被視為阻礙的行動。延誤和限制必須有明確的原因，并且仍然必須滿足信息和樣品請求。
Establishingclear communication protocols can help to facilitate a smooth inspection. That includes designating a point of contact for an inspection team and ensuring that all relevant personnel are available to address questions or concerns raised by investigators.
建立明確的溝通方案有助于促進順利檢查。這包括為檢查組指定一個聯絡點，并確保所有相關人員都可以解決調檢查員提出的問題或疑慮。
Postinspection Follow-Up: Following an inspection, facilities should review the FDA’s findings and take immediate action to address any identified issues. That can include implementing corrective and preventive actions (CAPAs) to address noncompliance and mitigate future occurrences.
檢查后跟進：檢查后，企業應審查 FDA 的檢查結果，并立即采取行動解決任何發現的問題。這可能包括實施糾正和預防措施 （CAPA） 來解決不合規問題并減少未來發生的情況。
Manufacturers shoulddocument all actions taken in response to inspection findings and report them to the FDA as required. Facilities must provide evidence of corrective actions and demonstrate ongoing compliance with FDA regulations.
制造商應記錄為應對檢查結果而采取的所有行動，并根據需要向 FDA 報告。企業必須提供糾正措施的證據，并證明持續符合 FDA 法規。
Continuous improvement is essential for maintaining compliance in the ever-evolving regulatory landscape. Manufacturers should review and update their compliance programs frequently to address new regulations and industry best practices, stay informed about changes in FDA guidance, and participate in industry forums and training programs.
持續改進對于在不斷變化的監管環境中保持合規性至關重要。制造商應經常審查和更新其合規計劃，以應對新的法規和行業最佳實踐，隨時了解FDA 指南的變化，并參與行業論壇和培訓計劃。
Continued Compliance
持續合規
Compliance with FDA inspection requirements is a critical aspect of ensuring the safety and efficacy of drugs and medical devices. The guidance document reviewed herein provides a framework for understanding the actions that constitute delaying, denying, limiting, or refusing an inspection. Facilities must understand the guidelines and align their practices with regulatory expectations to avoid severe consequences, including product adulteration designations and potential legal actions. To mitigate potential problems with the FDA, manufacturers should focus on maintaining clear, transparent, and proactive communication with the agency. Below are some specific actions that facility management can take to ensure compliance.
遵守 FDA 檢查要求是確保藥品和醫療器械安全性和有效性的關鍵方面。本文回顧的指導文件提供了一個框架，用于了解構成延遲、拒絕、限制或拒絕檢查的行為。企業必須了解指南，并將其做法與監管要求保持一致，以避免嚴重后果，包括商品摻假認定和潛在的法律訴訟。為了減輕FDA 的潛在問題，制造商應專注于與FDA保持清晰、透明和主動的溝通。以下是設施管理人員可以采取的一些具體措施來確保合規性。
• Communicate all requests for postponement in writing and include detailed explanations supported by evidence, such as maintenance schedules, emergency reports, and medical documentation for key personnel. Documentation not only demonstrates the company’s commitment to transparency, but also helps to prevent misunderstandings.
以書面形式傳達所有推遲申請，并附上有證據支持的詳細解釋，例如維護計劃、緊急報告和關鍵人員的醫療文件。文件不僅表明了公司對透明度的承諾，還有助于防止誤解。
• If an inspection is postponed for good cause, then provide the FDA with regular updates on the situation. For instance, if a facility is recovering from a cyberattack, updates could include the progress of system restorations and interim measures taken to maintain compliance.
如果檢查因正當理由而推遲，則定期向 FDA 提供有關情況的最新信息。例如，如果設施正在從網絡攻擊中恢復，則更新可能包括系統恢復的進度和為保持合規性而采取的臨時措施。
• Develop and regularly update an emergency-preparedness plan with protocols for communicating with the FDA during unforeseen events. The plan should outline how a manufacturer will handle situations such as natural disasters, pandemics, and cybersecurity breaches and keep the FDA informed and involved in real-time decision-making.
制定并定期更新應急準備計劃，其中包含在意外事件期間與 FDA 溝通的協議。該計劃應概述制造商將如何處理自然災害、流行病和網絡安全漏洞等情況，并讓 FDA 了解情況并參與實時決策。
• In complex situations, consult with regulatory experts who can guide your facility in navigating the scenario. Such professionals can assist with drafting communications, preparing documentation, and strategizing responses to meet FDA expectations.
在復雜情況下，請咨詢監管專家，他們可以指導你的設施駕馭這種情況。這些專業人員可以協助起草通信、準備文件和制定應對措施策略，以滿足FDA 的期望。
Maintaining transparency and cooperation during FDA inspections is essential to protecting public health and preserving trust in medical products. Manufacturers should review and update their internal protocols regularly to ensure inspection readiness and foster a culture of compliance. For further guidance, industry professionals should consult the full FDA guidance document referenced below and seek expert advice when necessary. A proactive approach will help facilities to meet their regulatory obligations and uphold the highest standards of product quality and safety.
在 FDA 檢查期間保持透明度和合作對于保護公眾健康和維護對醫療產品的信任至關重要。制造商應定期審查和更新其內部規程，以確保做好檢驗準備并培養合規文化。如需進一步指導，行業專業人士應查閱下面引用的完整FDA 指導文件，并在必要時尋求專家建議。積極主動的方法將幫助工廠履行其監管義務，并維護最高的產品質量和安全標準。
來源：Internet
