|
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ... [...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), but 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 not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Product Recall
A product recall is a request from a manufacturer to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller at risk of legal action. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. It can be difficult, if not impossible, to determine how costly can be releasing to the consumer a product that could endanger someone's life and the economic loss resulting from unwanted publicity. Recalls are costly. Costs include having to handle the recalled product, replacing it and possibly being held financially responsible for the consequences of the recalled product. A country's consumer protection laws will have specific requirements in regard to product recalls. Such regulations may include how much of the cost the maker will have to bear, situations in which a recall is compulsory (usually because the risk is b ... [...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. 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 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was use ... [...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 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 "enabling legislation." Enabling legislation typically has two parts: a substantive scope (typically using language such as "The Secretary shall promulgate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Botulism
Botulism is a rare and potentially fatal illness caused by a toxin produced by the bacterium ''Clostridium botulinum''. The disease begins with weakness, blurred vision, 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 be spread in several ways. The bacterial spores which cause it are common in both soil and water. 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 happens when the bacteria develops in the intestines and releases the toxin. This typically only occurs in children less than six months old, as protective mechanisms develop after that time. Wound botulism is found most often among those who inject street drugs. In this situation, spore ... [...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 s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
.jpg "Click for more on -> Food And Drug Administration")
