FDA Inspections Database

The Food and Drug Administration (FDA) recently released its new data set for the Inspections Database. ^1-2 The Inspections Database makes available the most recent inspection (up to two years of inspections) of a company. The final inspection classification for clinical trial investigators and Institutional Review Boards (IRB), as well as manufacturing, processing, and packing facilities’ final inspection classifications are disclosed.³ The inspection classification of facilities that hold an FDA-regulated and currently marketed product is also listed on the FDA inspection database.

Currently, there are three types of inspection classification: ⁴

1. No Action Indicated (NAI) - This type of inspection classification is given 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.”⁴
2. Voluntary Action Indicated (VAI) - “Occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance. Inspections classified with the VAI violations are typically more technical violations of the [Food Drug and Cosmetics Act]”⁴
3. Official Action Indicated (OAI) - This type of inspection classification is given 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)”.⁴

To view the FDA Inspection Classification Database Search, CLICK HERE.²

For more information on Search Form Fields, within the Inspection Classification Database Search, please visit FDA’s website http://www.accessdata.fda.gov/scripts/inspsearch/searchfields.cfm. ⁵

If you have any questions pertaining to the Inspections Database, please send an e-mail to FDAInspectionsClassficiations@fda.hhs.gov.³

To make a request for official counts of inspections, please send an e-mail to the FDA’s Office of Media Affairs at fdaoma@fda.hhs.gov., with the subject heading “Inspection Court”.³

Do you have any questions or comments about this blog? Feel free to leave your feedback!

-RSpelich ^_^

References

1. FDA. Inspection Classification Definitions. Last updated 05/24/11. Accessed 24 June 2013. Available at: http://www.fda.gov/ICECI/EnforcementActions/ucm223231.htm.
2. FDA. Inspection Classification Database Search. Data reported as of June 2013. Accessed 26 June 2013. Available at: http://www.accessdata.fda.gov/scripts/inspsearch/.
3. FDA. Inspections, Compliance, Enforcement, and Criminal Investigations. Last updated 07 June 2013. Accessed 24 June 2013. Available at: http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm.
4. FDA. Inspections. Accessed 24 June 2013. Available at: http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212061.pdf
5. FDA. More Information on Search Form Fields: Inspection Classification Database Search. Accessed 25 June 2013. Available at: http://www.accessdata.fda.gov/scripts/inspsearch/