Thursday, 25 July 2013

FDA Inspection Classification- NAI,VAI,OAI & Establishment inspection Report (EIR)


If regulatory non compliance observed during FDA inspection, the FDA inspector issues “Form 483” (Notice of Inspectional Observations) to the facility. The contents of the 483 comprise inspectional observations but do not represent a final Agency determination regarding compliance.

The company which receives a 483 should respond to the FDA addressing each item within 15 working days. A response is not compulsory but a good response can help the company avoid receiving a warning letter, or stronger enforcement actions including withholding of product approval or even a plant shutdown.

FDA provides initial classification of the inspection based on the observations noted during the inspection, the investigator’s report, and FDA District Office supervisory personnel review. With the exception of instances where procedures indicate that the relevant product center has the right of final classification, the final classification of the inspection is made by the FDA District Office. An inspection classification reflects the compliance status of the establishment at the time of the inspection, based on the observations documented. The conclusions of the inspection are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s).

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance. Inspections classified with VAI violations are typically more technical violations of the FDCA (The United States Federal Food, Drug, and Cosmetic Act).

An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.

If no enforcement action is contemplated, or after enforcement action is concluded, FDA provides inspected establishments with a final inspection report, called an Establishment Inspection Report (EIR), which includes:

  • 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.