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Corrective and preventive action ( CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.
GDocP interpretation. From the regulatory guidance above, additional expectations or allowances can be inferred by extension. Among these are: Prohibition against removing pages [10] – the removal of a page would obscure the data that were present, so this is not permissible.
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
(Reuters) - The U.S. health regulator on Thursday classified corrections made to the instructions for the use of blood pumps manufactured by Johnson & Johnson's Abiomed unit as most serious due...
Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483, [2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Laser-Assisted in Situ Keratomileusis ( LASIK ), commonly referred to as laser eye surgery or laser vision correction, is a type of refractive surgery for the correction of myopia, hyperopia, and an actual cure for astigmatism, since it is in the cornea. [1]
Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods.
In the United Kingdom, the procedure is offered primarily for myopic correction up to −5.00 diopters and up to −1.50 diopters of astigmatism. Fitting evidence for the leading lens designs indicates that procedures undertaken within these parameters have the highest probability of success.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
Validation and verification are procedures that ensure that medical devices fulfil their intended purpose. Validation or verification is generally needed when a health facility acquires a new device to perform medical tests.