FDA INSPECTION CLASSIFICATION - (NAI,VAI,OAI) & ESTABLISHMENT INSPECTON REPORT (EIR)
- Brief history of prior inspectional findings, including any action taken by FDA or corrective action taken by the firm in response to a previous inspection
- The investigator’s narrative report
- Any refusals, voluntary corrections, or promises made by the firm’s management
- Copies of forms the FDA issued to the firm during the inspection, including the FDA Form 483.