Database Code Definitions
MTF - Case closed with a Memo to File
NAI - No Action Indicated. No objectionable conditions or practices were found during the inspection.
VAI - Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily.
VAI1 - Correction made on site
VAI2 - No response requested
VAI2C - Consent problems found
VAI3 - Response requested
VAI3C - Case closed
VAI3F - Follow-up for cause inspection issued
VAI3R - Response received and accepted
VAIRC - 30-day response requested and case closed
VAIRR - 30-day response requested, received and accepted
VAIR - 30-day response requested
OAI - Official Action Indicated. Objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated.
OAIC - Completed
OAIR - Response requested
OAIRR - Response requested and accepted
OAIW - Warning letter issued
CANC - Cancelled. The inspection assignment was canceled before the inspection was started.
WASH - Washout. An inspection was initiated but no meaningful information could be obtained.
REF - Reference
CLIIL Deficiency Codes
Code of Federal
|00||No deficiencies noted||n/a|
|01||Records availability||21 CFR 312.62|
|02||Failure to obtain and/or document subject consent||21 CFR 312.60, 50.20, 50.27|
|03||Inadequate informed consent form||21 CFR 50.25|
|04||Inadequate drug accountability||21 CFR 312.60, 312.62|
|05||Failure to follow investigational plan||21 CFR 312.60|
|06||Inadequate and inaccurate records||21 CFR 312.62|
|07||Unapproved concomitant therapy||21 CFR 312.60|
|08||Inappropriate payment to volunteers||21 CFR 50.20|
|09||Unapproved use of drug before IND submission||21 CFR 312.40(d)|
|10||Inappropriate delegation of authority||21 CFR 312.7, 312.61|
|11||Inappropriate use/commercialization of IND||21 CFR 312.7, 312.61|
|12||Failure to list additional investigators on 1572||21 CFR 312.60|
|13||Subjects receiving simultaneous investigational drugs||21 CFR 312.60|
|14||Failure to obtain or document IRB approval||21 CFR 312.60, 62, 66; 56.103|
|15||Failure to notify IRB of changes, failure to submit progress reports||21 CFR 312.66|
|16||Failure to report adverse drug reactions||21 CFR 312.64, 312.66|
|17||Submission of false information||21 CFR 312.70|
|19*||Failure to supervise or personally conduct the clinical investigation||21 CFR 312.60|
|20*||Failure to protect the rights, safety, and welfare of subjects||21 CFR 312.60|
|21*||Failure to permit FDA access to records||21 CFR 312.68|
DA - Data Audit: An inspection in which the focus is on verification of study data.
FC - For Cause: An inspection in which the focus is on the conduct of the study by the Clinical Investigator.
IG - Information Gathering