FDA CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)
标准简介
CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)[附网盘链接]是于不久前发布的FDA标准，适用于U.S。标准截图
![CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)[附网盘链接]](/img/20210914103651ujpoj.jpg)
标准文档说明
标准文档类型为CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Compliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs) Guidance for FDA Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction: The purpose of this document is to provide guidance for FDA staff when receiving and reviewing private laboratory analytical packages (PLAPs). Importers typically submit PLAPs to FDA to provide information regarding the admissibility of articles that are held under detention without physical examination (DWPE) due to the appearance of a violation. The policy described in this document applies to: 1) FDA compliance personnel review of the non-technical aspects of a PLAP; and 2) FDA compliance personnel determination of admissibility after the technical review of a PLAP is completed by an ORA Field Laboratory. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background: Section 801 of the Federal Food Drug & Cosmetic Act (FD&C Act) authorizes FDA to refuse admission of imported articles if it appears from the examination of such samples or otherwise that the article is in violation of applicable provisions of the FD&C Act. To carry out the provisions of section 801(a), FDA may detain articles that appear violative and inform the importer of the nature of the violation and the right to introduce testimony regarding the admissibility of the article (see 21 CFR 1.94). Depending on the information submitted by the importer, the article may either be permitted or refused entry into the United States. 3
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