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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DI STRICT ADDRESS AND PHONE NUMERATE(S) OF INSPECTION300 River Place, Suite 5900 Detroit, MI 48 20 7 (313) 393 8100 Fax : (313)393
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Any organization or individual that has received a Form 483 from the FDA requiring a response.
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What is 483 roundup fda cites?
483 roundup FDA cites are reports issued by the Food and Drug Administration (FDA) to document observations of non-compliance with regulations during inspections.
Who is required to file 483 roundup fda cites?
Manufacturers, food processors, and distributors regulated by the FDA are required to file 483 roundup FDA cites if any violations are found during an inspection.
How to fill out 483 roundup fda cites?
To fill out 483 roundup FDA cites, the company must address each observation made by the FDA inspector, provide a plan of corrective action, and submit the report to the FDA.
What is the purpose of 483 roundup fda cites?
The purpose of 483 roundup FDA cites is to inform companies of violations found during inspections, prompt corrective action, and prevent potential harm to consumers.
What information must be reported on 483 roundup fda cites?
483 roundup FDA cites must include details of each observed violation, the potential risks to public health, and the company's plan for correcting the issues.
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