World of Compliance Module

Inspection Classifications

OC evaluates these reports and determines if there is a regulatory violation. If a violation exists, OC determines if there is evidence that supports a violation, the significance and if the violation impacts data integrity and/or human subject protection.

After the evaluation, OC informs the party that's been inspected, summarizing any significant findings.

Inspections fall into three classifications:

• No Action Indicated - no regulatory action is indicated; no regulatory violations were found.
• Voluntary Action Indicated (VAI) - FDA will ask the firm to voluntarily take corrective action. If violations are found that can't be corrected (since they have already occurred), FDA seeks assurances that the violations won't happen again.
• Official Action Indicated - FDA issues a warning letter that outlines violations found and requests a written corrective action plan. If the investigator does not provide an adequate response, FDA may take further regulatory action.