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  2. The FDA issued a ‘do not eat’ oyster advisory for Florida ...

    www.aol.com/fda-issued-not-eat-oyster-232809040.html

    The FDA issued a ‘do not eat’ oyster advisory for Florida, New York, 11 other states. ... There’s an FDA advisory about frozen half shell oysters from South Korean company Dai One Food.

  3. Oysters sold in 15 states recalled over norovirus risk

    www.aol.com/news/oysters-sold-15-states-recalled...

    Oyster and Manila clams advisory The implicated products in the Dec. 16 advisory include oysters and Manila clams harvested from Nov. 15, 2024, and Dec. 11, 2024, by Rudy’s Shellfish in ...

  4. FDA issues warning over oysters contaminated with paralytic ...

    www.aol.com/news/fda-issues-warning-over-oysters...

    The U.S. Food and Drug Administration has issued a warning to avoid shellfish from Oregon and Washington that may be potentially “contaminated with paralytic shellfish toxins.”

  5. FDA warning letter - Wikipedia

    en.wikipedia.org/wiki/FDA_Warning_Letter

    The FDA considers a warning letter informal and advisory. It communicates the agency's position on a matter, but does not commit the FDA to an enforcement action. For that reason, the FDA does not consider a warning letter a final action on which it can be sued.

  6. Form FDA 483 - Wikipedia

    en.wikipedia.org/wiki/Form_FDA_483

    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 ...

  7. Generally recognized as safe - Wikipedia

    en.wikipedia.org/wiki/Generally_recognized_as_safe

    FDA posts status of the review as either without further questions (as a position of "no objection") or the petition is withdrawn by the applicant. [ 4 ] For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of ...

  8. FDA has serious warning for oyster eaters in Florida, North ...

    www.aol.com/fda-serious-warning-oyster-eaters...

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  9. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.