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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D4SIR ICT ADORE88 AND PHONE NUMBER DATE(S) OF INSPECTION 300 River Place, Suite 5900 Detroit, MI 48207 (313) 393-8100 Fax :(313)
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What is perrigo 483 form?
The Perrigo 483 form is a document issued by the U.S. Food and Drug Administration (FDA) to report observations made during inspections of Perrigo Pharmaceutical facilities.
Who is required to file perrigo 483 form?
Perrigo Pharmaceuticals, as the inspected entity, is required to file the Perrigo 483 form with the FDA.
How to fill out perrigo 483 form?
The Perrigo 483 form is completed by providing a detailed response to each observation made by the FDA during the inspection. The form requires accurate and complete information regarding the corrective actions taken or planned by Perrigo Pharmaceuticals.
What is the purpose of perrigo 483 form?
The purpose of the Perrigo 483 form is to officially document the observations made by the FDA during inspections of Perrigo Pharmaceutical facilities. It serves as a tool for communication between the FDA and Perrigo Pharmaceuticals regarding compliance with regulations and the need for corrective actions.
What information must be reported on perrigo 483 form?
The Perrigo 483 form must include a description of each observed violation, the specific regulations or requirements violated, and any resulting corrective actions taken or planned by Perrigo Pharmaceuticals.
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