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Examples of recently issued 483s are available in ORAs Electronic Reading Room. Questions regarding Inspection Observations may be directed by email to FDAInspectionsObservations@fda.hhs.gov.
If FDA finds a companys 483 response inadequate, it could result in a warning letter. If issues continue to occur there could even be additional actions such as prosecution or civil penalties. The most drastic action the Agency could take is a consent decree.
An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice. You need to respond in writing within 15 days of receiving both a 483 and a warning letter. Youre not obligated to handle observations cited by inspectors in a Form 483.
Once a warning letter has been issued, you will have 15 days to respond. The FDA schedules a follow-up inspection for roughly 30 days after it receives the warning letter response. In this second inspection, the FDA determines the effectiveness and adequacy of the companys corrective actions.
If FDA finds a companys 483 response inadequate, it could result in a warning letter. If issues continue to occur there could even be additional actions such as prosecution or civil penalties. The most drastic action the Agency could take is a consent decree.

People also ask

Prepare a written response within 15 days Within fifteen days the FDA-483 was issued, executives should prepare a written response. Although its not required, one should always be sent, as a good response can prevent the FDA from issuing a Warning Letter.
Theoretically, Form FDA 483s are public information and, thus, are available through the FDAs Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone. That said, requesting a 483 can be costly and may take a lot of time.
Warning Letters are issued for violations of regulatory significance that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agencys principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act).
Theoretically, Form FDA 483s are public information and, thus, are available through the FDAs Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone. That said, requesting a 483 can be costly and may take a lot of time.
Prepare a written response within 15 days Within fifteen days the FDA-483 was issued, executives should prepare a written response. Although its not required, one should always be sent, as a good response can prevent the FDA from issuing a Warning Letter.

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