FDA Inspection Readiness: After the Inspection
In the final part of the three-part FDA inspection readiness series, we will go into detail about what to expect after the inspection is complete. If you missed the previous blogs, FDA Inspection Readiness: Preparing for an Inspection and FDA Inspection Readiness: During the Inspection, you may want to jump back to the beginning to get details on the entire FDA inspection process.
After the Inspection
The lead inspector(s) will meet with the Principal Investigator (PI) and discuss the inspection, provide feedback, and share inspection observations. If the inspector(s) found any practices or situations deviating from the protocol, good clinical practices (GCPs), or federal regulations, they will issue a Form FDA 483 and list the violations. The PI should review each violation and discuss them in detail with the inspector(s), make corrections if possible, and describe the next steps, such as corrective actions with timeframes for resolutions.
If a Form FDA 483 is issued, the FDA allows institutions 15 business days to provide a response to observations, including a summary of all corrective action plans and timelines. If the PI and site management disagree with any of the observations, say so with rationale and documentation. Following the inspection, the lead inspector prepares a written report and submits it to FDA headquarters for evaluation. The final written FDA report, describing the observations, is known as the establishment inspection report (EIR), and is available to the site approximately 3-6 months after the inspection. It is also available to the public through the Freedom of Information Act (FOI). Following the inspection, if an inspector did not issue a Form FDA 483, inspectional observations, the inspection will be classified as no action indicated (NAI). If a Form FDA 483 was issued, the inspection will be classified either as voluntary action indicated (VAI) or official action indicated (OAI). VAI means one or more inspection observations (non-compliance with regulations) were noted, but the observations do not justify further regulatory actions and any action to correct the issue(s) noted is left to the investigator to take voluntarily. OAI requires FDA Compliance Branch review and may result in regulatory and/or administrative actions by the FDA.
When an investigative site is notified of an FDA investigation, it is essential to prepare all staff members. Preparation will ensure the site has all the documents necessary for the inspection, the staff members are trained on their roles and responsibility during the inspection, and the site is aware of its responsibilities for any follow-up with the FDA, if applicable.
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