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Class I Recall
The United States Food and Drug Administration has published certain product recall policies applicable to consumer products. FDA-Industry Co-operation The manufacturers or distributors of the product carry out most recalls of products regulated by FDA voluntarily. In some instances, a company discovers that one of its products is defective and recalls it entirely on its own. In others, FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply. If the firm does not recall the product, then FDA can seek legal action under the '' FD&C Act''. These include seizure of available product, and/or injunction of the firm, including a court request for recall of the product. This cooperation between FDA and its regulated industries has proven over the years to be the quickest and most reliable method to remove potentially dangerous products from the market. This method has been successful because it is in the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States asserts sovereignty over five Territories of the United States, major island territories and United States Minor Outlying Islands, various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's List of countries and dependencies by area, third-largest land area and List of countries and dependencies by population, third-largest population, exceeding 340 million. Its three Metropolitan statistical areas by population, largest metropolitan areas are New York metropolitan area, New York, Greater Los Angeles, Los Angel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Product Recall
"Product Recall" is the twenty-first episode of the third season of the American comedy television series '' The Office'' and the show's forty-ninth episode overall. The series depicts the everyday lives of office employees in the Scranton branch of the fictional Dunder Mifflin Paper Company. In this episode, the company deals with the consequences of an offending watermark that appeared on several reams of paper. Michael Scott ( Steve Carell) holds a poorly attended press conference, Jim Halpert ( John Krasinski) and Andy Bernard ( Ed Helms) head to a high school that printed their prom invitations on the paper to apologize, and Creed Bratton ( Creed Bratton) frames an employee at the paper mill to keep his job. The episode was written by Justin Spitzer and Brent Forrester, and was directed by Randall Einhorn, the series director of photography. The cast found the scene in which Jim impersonates Dwight Schrute ( Rainn Wilson) to be hilarious and had trouble keeping ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FD&C Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patien ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Code Of Federal Regulations
In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulatory law, 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 broad areas subject to federal regulation. The CFR annual edition is published as a special issue of the ''Federal Register'' by the Office of the Federal Register (part of the National Archives and Records Administration) and the Government Publishing Office. In addition to this annual edition, the CFR is published online on the Electronic CFR (eCFR) website, which is updated daily. Background Congress frequently delegates authority to an executive branch agency to issue regulations to govern some sphere. These statutes are called "authorizing statute" or "enabling statute" (or "authorizing legislation"). Authorizing statutes typically have two parts: (1) a substantive sc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Botulism
Botulism is a rare and potentially fatal illness caused by botulinum toxin, which is produced by the bacterium ''Clostridium botulinum''. The disease begins with weakness, blurred vision, Fatigue (medical), feeling tired, and trouble speaking. This may then be followed by weakness of the arms, chest muscles, and legs. Vomiting, swelling of the abdomen, and diarrhea may also occur. The disease does not usually affect consciousness or cause a fever. Botulism can occur in several ways. The bacterial spores which cause it are common in both soil and water and are very resistant. They produce the botulinum toxin when exposed to low oxygen levels and certain temperatures. Foodborne botulism happens when food containing the toxin is eaten. Infant botulism instead happens when the bacterium develops in the intestines and releases the toxin. This typically only occurs in children less than one year old, as protective mechanisms against development of the bacterium develop after that age ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Contamination Control
Contamination control is the generic term for all activities aiming to control the existence, growth and proliferation of contamination in certain areas. Contamination control may refer to the atmosphere as well as to surfaces, to particulate matter as well as to microbes and to contamination prevention as well as to decontamination. Function The aim of all contamination control activities is to permanently ensure a sufficient level of cleanliness in controlled environments. This is accomplished by maintaining, reducing, or eradicating viable and non-viable contamination for either sanitary purposes or in order to maintain an efficient rate of production. Usage One of the most common environments that incorporates contamination control into its standards protocol is the cleanroom. There are many preventive procedures in place within a cleanroom environment. They include subjecting cleanroom staff to strict clothing regulations, and there is often a gowning room where the st ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
