FDA determines compliance with the GMP requirements set forth in the Quality System (QS) regulation primarily by factory
inspections. An FDA inspection of an establishment, however, can be initiated for a number of reasons. The reasons may be
general, such as routine scheduling or a need to obtain data on industries new to FDA or, the reasons may be specific, such as
investigation of a consumer or trade complaint, a product defect report, an adverse reaction, or a death. FDA also conducts
inspections under the Compliance Status Information Systems (Com STAT) on behalf of the Veterans Administration (VA),
Department of Defense (DOD), and Health Resources and Services Administration (HRSA). Upon arrival, the investigator
presents his/her credentials and issues a Notice of Inspection form FDA 482. At the end of the inspection, observations are
recorded on form FDA 483, List of Observations, and discussed with the manufacturer's management. Later the investigator
will write an Establishment Inspection Report (EIR), which is a detailed record of the inspection and findings. |
