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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 ...
An FDA warning letter is an official message from the United States Food and Drug ... Unlike the Form FDA 483, the warning letter cites regulatory references for each ...
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.
"Following the change in Administration, the Department of Justice has reconsidered the United States’ position in this case," Deputy Solicitor General Curtis Gannon wrote in a letter to the court.
The European Union sent a warning letter to X owner Elon Musk on Monday reminding him of the bloc’s rules against promoting “harmful content” ahead of the billionaire tech mogul’s ...
A former girlfriend of rocker Jim Morrison is speaking out on her time with the late Doors frontman — including an alleged instance of sexual assault.. Judy Huddleston is one of the many members ...
FDA warning letter; Federal Food, Drug, and Cosmetic Act of 1938; First-in-class medication; Food Additives Amendment of 1958; ... Form FDA 483; G. Generally ...
A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 people. [2] [3] [4] In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal ...