Sarepta shares surge after surprise approval of Duchenne Muscular Dystrophy drug

Bristol Myers, flush with pair of CAR-T approvals, blueprints first cell therapy factory in Europe

In December, the FDA hit a Lonza facility producing viral vectors for Breyanzi with a Form 483, a development that might have played a role…

FDA Unveils Extensive Manufacturing Violations at Emergent

… unusual step of issuing the closeout report (form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility.

FDA finds mess of sterility problems at Emergent

… cross contamination and failure to keep the facility clean and listed nine violations on the inspection closeout report, also known as FDA Form 483.

Emergent BioSolutions Hit with FDA Form 483

In addition, FDA inspectors noted in the Form 483 that the building used to manufacture the viral vaccine drug substance was “not of suitable size, …

Key FDA Drug and Device Updates

For remote interactive evaluations, FDA will not issue a Form 482, Notice of Inspection, Form 483, or an Inspectional Observations form. Otherwise …

Why remote drug manufacturing evaluations won’t reduce FDA’s backlog of inspections

… said that there’s a concern with how the FDA positioned these remote evaluations because although there may not be a Form 483 with observations …

Statement on Issuance of Form FDA 483 at Emergent Bayview Facility

GAITHERSBURG, Md., April 21, 2021 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration (FDA) has completed its inspection of …

COVID-19 LIVE UPDATES | Senses dulled by Covid-19, French wine tasters fear for livelihood

The FDA’s inspection closeout report, also known as “FDA Form 483“, cited observations including failure to train personnel to avoid cross …

FDA finds multiple problems at Baltimore plant that ruined J&J vaccine doses

The report, known as FDA Form 483, says the plant operated by Emergent BioSolutions “is not maintained in a clean and sanitary condition.

FDA Shuts Down Emergent Vaccine Facility

The FDA form 483 inspection report issued a year ago described inadequate controls for computer and records systems, disregard of established test …

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Shares of Sarepta Therapeutics Inc soared 31% on Friday after U.S. regulators shocked Wall Street by approving the company’s treatment for a muscle-wasting disorder less than four months after rejecting the drug over safety concerns.