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View Full Version : What do "OAI" "VAI" and "NAI" used in FDA QSIT manual mean in inspections?


TJG954
21st June 2007, 04:18 PM
These are used in FDA QSIT manual, but doesn't say what they stand for.
:confused:

Benjamin28
21st June 2007, 04:31 PM
You can try this:

http://www.chemie.fu-berlin.de/cgi-bin/acronym


:biglaugh:

Jim Wynne
21st June 2007, 04:31 PM
These are used in FDA QSIT manual, but doesn't say what they stand for.
:confused:

According to information on this site (http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=5786), they stand for Official Action Indicated, Voluntary Action Indicated and No Action Indicated.

Ajit Basrur
25th June 2007, 01:55 AM
These are used in FDA QSIT manual, but doesn't say what they stand for.
:confused:

These are the Inspection classification codes. Apart from the ones you have mentioned, the other inspectional codes are as follows -

Inspection Classification Codes:
CAN: Canceled

NAI: No Action Indicated. No objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).

NCC: Non Classified

NIM: No Inspection Made.

OAI: Official Action Indicated. Regulatory and administrative actions will be recommended.

PEN: Pending review and classification.

RTC: Refer to Center: Establishment Inspection Report had been forwarded to Center for final review and classification.

VAI: Voluntary Action Indicated. Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

WO: Washout: Firm was visited or inspected, however, not performing regulated studies at time of inspection.

Refer for more details at http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_foreign.htm