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If the firm markets other FDA-regulated products and the issue(s) affect marketed products—or the inspection extended to marketed products included on the FDA 483, then they may issue a Warning Letter These include the following statement: "Due to the deficiencies listed on the attached FDA 483 we are recommending to the center that approval ...
More than 1,000 pounds of cat food has been recalled due to salmonella contamination. The U.S. Food and Drug Administration (FDA) recently announced that Blue Ridge Beef was recalling 1,350 pounds ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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 ...
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
The FDA, however, imposes such rules on behalf of consumers who may have serious reactions to one of several “major food allergens.” There are nine such foods: crustacean shellfish, eggs, fish ...
In China, a warning text (警示语) may be added to a package insert, either voluntarily by the manufacturer or at the request of NMPA (formerly CFDA, the Chinese counterpart of FDA). Although no formatting requirement is found in law, the typical formatting is similar to the American counterpart with boxed text at the top of the insert.
FDA rules require food manufacturers to state whether their products contain or may have come into contact with major allergens, including milk, eggs, fish, crustacean shellfish, tree nuts ...