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  5. Clinical Investigator Inspection List (CIIL) Database Codes
  1. Enforcement Activities | FDA

Clinical Investigator Inspection List (CIIL) Database Codes

Database Code Definitions

CIIL Search Page

The following codes occur in the CLIIL database: Classification, Deficiency, and Inspection Type.  Some codes are no longer being used, but they still appear in the database.

 Classification Codes

  • 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 

 Deficiency Codes

CLIIL Deficiency Codes



Code of Federal
Regulations (CFR) Reference

00No deficiencies notedn/a
01Records availability21 CFR 312.62
02Failure to obtain and/or document subject consent21 CFR 312.60, 50.20, 50.27
03Inadequate informed consent form21 CFR 50.25
04Inadequate drug accountability21 CFR 312.60, 312.62
05Failure to follow investigational plan21 CFR 312.60
06Inadequate and inaccurate records21 CFR 312.62
07Unapproved concomitant therapy21 CFR 312.60
08Inappropriate payment to volunteers21 CFR 50.20
09Unapproved use of drug before IND submission21 CFR 312.40(d)
10Inappropriate delegation of authority21 CFR 312.7, 312.61
11Inappropriate use/commercialization of IND21 CFR 312.7, 312.61
12Failure to list additional investigators on 157221 CFR 312.60
13Subjects receiving simultaneous investigational drugs21 CFR 312.60
14Failure to obtain or document IRB approval21 CFR 312.60, 62, 66; 56.103
15Failure to notify IRB of changes, failure to submit progress reports21 CFR 312.66
16Failure to report adverse drug reactions21 CFR 312.64, 312.66
17Submission of false information21 CFR 312.70
19*Failure to supervise or personally conduct the clinical investigation21 CFR 312.60
20*Failure to protect the rights, safety, and welfare of subjects21 CFR 312.60
21*Failure to permit FDA access to records21 CFR 312.68

 * Codes 19, 20, and 21 became effective October 1, 2005.

 Inspection Type Codes

  • 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


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