An FDA inspection might include review of policies and procedures.
Food and Drug Administration (FDA) inspections are conducted by the Bioresearch Monitoring Program (BIMO) to ensure human research subjects are not at any undue risk and to verify any data submitted is of the highest quality. An inspection can occur when a company has submitted a marketing application or when a series of adverse events have been reported to the FDA by the company, resulting in a "for-cause" inspection. Understanding the FDA inspection procedures can help researchers and manufacturers prepare for this process.
Pre-inspection
FDA inspection assignments are made to a district office, in which case the FDA inspector might or might not announce the visit. The inspection will be either a routine or for-cause inspection.
Inspection
FDA personnel will arrive on-site and present credentials along with form FDA 482, which is a notice of inspection. Inspections are conducted during normal business hours. Documents that may be inspected include standard operating procedures, policies, study folders, meeting minutes, institutional review board (IRB) documentation and correspondence, risk determination for devices, correspondence with study stakeholders, organizational charts, training records, complaints and databases. Any part of the facility may be inspected, including manufacturing, filing and assembling, and laboratories. A meeting will be held between management and the FDA inspector at the end of the inspection, in which Form 483, inspectional observations for significant deviations from the regulations, will be issued. There is an opportunity to respond to observations.
Post-inspection
The FDA inspector prepares an establishment inspection report (EIR) that is combined with Form 483 and supporting documentation to be forwarded to the Center for Compliance. A final classification of the inspection is made.
Inspection Classification
An FDA inspection might result in several classifications, including "no action indicated", "voluntary action indicated" or "official action indicated". "No action indicated" means there were no objectionable conditions or findings. "Voluntary action indicated" means an inspector found objections, but none were severe enough to take regulatory action. "Official action indicated" requires regulatory action because serious objectionable conditions were found.
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