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Get the free Example of FDA 482Notice of Inspection (PDF) - Maine.gov

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMERATE(S) OF INSPECTIONS Customhouse Rm900 2nd & Chestnut St Philadelphia, PA 19106 (215)5974390 Ext:4200
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01
Obtain a copy of the FDA Form 482 Notice from the FDA website or your local FDA office.
02
Provide all requested information accurately and completely on the form.
03
Include any supporting documentation or evidence as necessary.
04
Review the completed form for errors or missing information before submitting.
05
Submit the completed FDA Form 482 Notice to the appropriate FDA office or contact person.

Who needs example of fda 482notice?

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Companies or individuals who have been notified by the FDA of a potential violation or issue that requires a response.
02
Those who are in the process of an FDA inspection and have been asked to provide specific information or documentation.
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FDA Form 482 is an Inspectional Observation or 483 Notice, issued by the U.S Food and Drug Administration (FDA) to notify a company of objectionable conditions found during an inspection.
Any company or facility that is subject to FDA inspections may be required to file a FDA 482 Notice.
The FDA 482 Notice should be filled out accurately and completely, addressing all the objectionable conditions found during the inspection.
The purpose of the FDA 482 Notice is to officially notify the company or facility of the objectionable conditions found during an FDA inspection.
The FDA 482 Notice must include details of the objectionable conditions found during the inspection, as well as any actions taken or planned to address these conditions.
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