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What is the most common 483 observation?

What are the most common FDA 483 observations? Inadequate or insufficient testing of products or raw materials. Failure to properly handle, store, or label materials. Failure to establish or maintain adequate records or logs. Failure to properly report adverse events or incidents.

How serious is an FDA 483?

An FDA Form 483 is a list of deficiencies that the FDA sends to a company post-inspection outlining what they think needs to be remediated. It is strongly suggested that a company responds to these forms thoughtfully and aggressively with corrective actions.

What is the difference between a 483 and a warning letter from the FDA?

Lets recap. An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice.

What happens after a 483?

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.

Is a warning letter worse than a 483?

A warning letter is far more serious than a 483 observation. Any violations must be dealt with before you can meet compliance and bring your medical device to market. Its also possible to receive 483 observations and warning letters at the same time.

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