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DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMERATE(S) OF INSPECTION12 4 20 Park lawn Drive, Room 2032
Rockville, MD 2085 712/ 4 /2023 12/15/2023*
FEJNUMBER300
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How to fill out fda-issues-form-483-to-sun-pharmaceutical-industries
How to fill out fda-issues-form-483-to-sun-pharmaceutical-industries
01
Obtain the FDA-issued Form 483 from the FDA website or through official channels.
02
Review the form carefully for any specific instructions or guidelines provided by the FDA.
03
Fill out the required sections of the form accurately and completely, providing any requested information or documentation.
04
Ensure that all responses are truthful and in compliance with FDA regulations and requirements.
05
Double-check the completed form for any errors or omissions before submitting it to the FDA.
Who needs fda-issues-form-483-to-sun-pharmaceutical-industries?
01
Sun Pharmaceutical Industries, or any pharmaceutical company that has received a Form 483 from the FDA, would need to fill out the FDA-issued Form 483.
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What is fda-issues-form-483-to-sun-pharmaceutical-industries?
This form is a notification from the FDA to Sun Pharmaceutical Industries regarding violations observed during an inspection.
Who is required to file fda-issues-form-483-to-sun-pharmaceutical-industries?
Sun Pharmaceutical Industries is required to file this form.
How to fill out fda-issues-form-483-to-sun-pharmaceutical-industries?
The form must be filled out by detailing the violations observed by the FDA during the inspection.
What is the purpose of fda-issues-form-483-to-sun-pharmaceutical-industries?
The purpose of this form is to notify Sun Pharmaceutical Industries of the violations found and to request corrective actions.
What information must be reported on fda-issues-form-483-to-sun-pharmaceutical-industries?
The form must include details of the violations observed, the specific regulations violated, and any proposed corrective actions.
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