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Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
OMB Circular A 87, "Cost Principles for State, Local, and Indian Tribal Governments" (2 CFR part 225) – This circular includes the 50 States of the United States and the District of Columbia (Washington, D.C.), any agency or instrumentality of these governments—and any county, parish, municipality, city, town, State-designated Indian tribal ...
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
A few volumes of the CFR at a law library (titles 12–26) In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent ...
Good tissue practice (GTP) is one of the "GxP" requirements derived from good manufacturing practice.The rule was written and is enforced by the U.S. Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research.
Part I: Background, Purpose, and Applicability – Presents a brief description of the history of the Single Audit, defines the purpose of the OMB Circular A-133, and establishes where and why the Single Audit applies. [2] Part II: Matrix of Compliance Requirements – This section is a table which details the federal programs which are common ...
An Annual Comprehensive Financial Report (ACFR), formerly called a Comprehensive Annual Financial Report (CAFR)) [1] is a set of U.S. government financial statements comprising the financial report of a state, municipal or other governmental entity that complies with the accounting requirements promulgated by the Governmental Accounting Standards Board (GASB).