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8 Jun 2016

Is the FDA Form 483 is an all-inclusive list of every possible deviation from law and regulation?

No. Generally it does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483.

FDA investigators are instructed to note only what they saw during the course of the inspection.

Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.

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