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1. DISTRICT OFFICE ADDRESS AND PHONE NO.DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationTO2. NAME AND TITLE OF INDIVIDUAL6. DATE OF REQUEST3. FIRM NAME7. TIME OF REQUEST a.m.4.
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How to fill out form fda 482 request
How to fill out form fda 482 request
01
Begin by downloading Form FDA 482 from the FDA's official website.
02
Fill in the date at the top of the form.
03
Provide the name and address of the firm or individual being inspected.
04
Specify the reason for the inspection in the designated section.
05
Include the relevant details about the subject matter of the inspection.
06
Sign and date the form at the bottom.
07
Make copies for your records and submit to the appropriate FDA office.
Who needs form fda 482 request?
01
FDA 482 is needed by FDA inspectors when conducting inspections of businesses regulated by the FDA.
02
It is also necessary for individuals or entities that are being inspected.
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What is form fda 482 request?
Form FDA 482 is a document used by the U.S. Food and Drug Administration (FDA) to notify an establishment that an inspection will be conducted. It serves as a formal notice of inspection.
Who is required to file form fda 482 request?
Form FDA 482 is typically filed by FDA investigators or inspectors, not by entities or individuals. It is a part of the agency's regulatory process during inspections.
How to fill out form fda 482 request?
Form FDA 482 is filled out by FDA officials during the inspection process. It requires specific details about the inspection, including the purpose and scope, but is not filled out by external parties.
What is the purpose of form fda 482 request?
The purpose of Form FDA 482 is to formally notify an establishment that an inspection is forthcoming and outline the scope and purpose of the inspection.
What information must be reported on form fda 482 request?
The form must include information such as the name of the establishment, the reason for the inspection, the date and time of the inspection, and the identity of the investigator.
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