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that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment Identification) number.

Observations

This section starts with a "disclaimer" that the form contains the observations of the inspector and does not necessarily "represent a final Agency determination

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