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Inspection Reports

FDA inspections are conducted by investigators working out of the agency's field offices and can encompass factories, warehouses, and establishments in which foods, drugs, devices, veterinary products or cosmetics are manufactured, processed, packed or held for introduction into interstate commerce. Clinical investigators are also inspected in connection with the testing of investigational drugs or devices. In particularly grave situations, the FDA may also issue the inspected company a Warning Letter, which is releasable under the Freedom of Information Act. In January 2015, FDA removrd pre-2005 Warning Letters from their website; FOI Services fills this gap with a complete collection of Warning Letters from 1992 to April 2008.

All inspections generate an Establishment Inspection Report (EIR), prepared by FDA's investigator immediately after the inspection. In addition, observations of objectionable or violative conditions are recorded on a form FD-483 (483), presented to the inspected firm at the conclusion of the inspection. Both the EIR and 483 are generally disclosable under the Freedom of Information Act.

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