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  2. FDA warning letter - Wikipedia

    en.wikipedia.org/wiki/FDA_Warning_Letter

    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. ... a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.

  3. Corrective and preventive action - Wikipedia

    en.wikipedia.org/wiki/Corrective_and_preventive...

    The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. The Eight disciplines problem solving method ...

  4. Good documentation practice - Wikipedia

    en.wikipedia.org/wiki/Good_documentation_practice

    Good documentation practice. Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various ...

  5. US FDA classifies corrections to instructions for Abiomed's ...

    www.aol.com/news/us-fda-classifies-recall...

    March 21, 2024 at 3:47 PM. (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 ...

  6. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    Title 21 CFR Part 11. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic ...

  7. Complete Response Letter - Wikipedia

    en.wikipedia.org/wiki/Complete_Response_Letter

    Complete Response Letter. In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will ...

  8. Form FDA 483 - Wikipedia

    en.wikipedia.org/wiki/Form_FDA_483

    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.

  9. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the 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 and over-the-counter pharmaceutical drugs (medications), vaccines ...

  10. Medical prescription - Wikipedia

    en.wikipedia.org/wiki/Medical_prescription

    Predating modern legal definitions of a prescription, a prescription traditionally is composed of four parts: a superscription, inscription, subscription, and signature. The superscription section contains the date of the prescription and patient information (name, address, age, etc.). The symbol "℞" separates the superscription from the ...

  11. Types of rape - Wikipedia

    en.wikipedia.org/wiki/Types_of_rape

    Corrective rape is targeted rape against non-heterosexuals as a "punishment for violating gender roles". It is a form of hate crime against LGBT individuals, mainly lesbians, in which the rapist justifies the act as an acceptable response to the victim's perceived sexual or gender orientation and a form of punishment for being gay.