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DEPARTMENT OF HEALTH AND HUMAN\”I Service FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMERATE(S) OF INSPECTION10903 New Hampshire Ave, Bldg71, Rm 5054 Silver Spring, MD 20993 0002 (240)402
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What is FDA Form 483 Fujinomiya?
FDA Form 483 is a document issued by the FDA to indicate that an inspection has revealed any conditions that may constitute violations of the Federal Food, Drug, and Cosmetic Act.
Who is required to file FDA Form 483 Fujinomiya?
FDA Form 483 is issued to firms inspected by the FDA; it is not filed by individuals but rather presented by FDA inspectors to the management of the inspected facility.
How to fill out FDA Form 483 Fujinomiya?
FDA Form 483 is completed by FDA inspectors during inspections, detailing observations of non-compliance. The facility does not fill it out; they receive it post-inspection.
What is the purpose of FDA Form 483 Fujinomiya?
The purpose of FDA Form 483 is to inform management of any observations made during an inspection that may violate regulatory standards, prompting a response from the facility.
What information must be reported on FDA Form 483 Fujinomiya?
FDA Form 483 must report specific observations from the inspection, including details about deviations from regulatory requirements and any public health concerns.
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