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                Enforcement Activities | FDA

Enforcement Activities | FDA

                        Over-the-Counter (OTC) Drugs Branch


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          Enforcement Activities | FDA
          Clinical Investigator Inspection List (CIIL) Database CodesEnforcement Activities | FDA Clinical Investigator Inspection List (CIIL) Database Codes
  
  	
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CIIL Search Page

The CLIIL database contains codes for Inspection Classification, Deficiency, and Type as described below.

**Classification Codes**

**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.
	**OAI**- Official Action Indicated. Objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated.

Deficiency Codes

**Code**
			**Deficiency**
			**Code of Federal 
			Regulations (CFR) Reference**00
			No deficiencies noted
			n/a01
			Records availability
			21 CFR 312.6202
			Failure to obtain and/or document subject consent
			21 CFR 312.60, 50.20, 50.2703
			Inadequate informed consent form
			21 CFR 50.2504
			Inadequate drug accountability
			21 CFR 312.60, 312.6205
			Failure to follow investigational plan
			21 CFR 312.6006
			Inadequate and inaccurate records
			21 CFR 312.6207
			Unapproved concomitant therapy
			21 CFR 312.6008
			Inappropriate payment to volunteers
			21 CFR 50.2009
			Unapproved use of drug before IND submission
			21 CFR 312.40(d)10
			Inappropriate delegation of authority
			21 CFR 312.7, 312.6111
			Inappropriate use/commercialization of IND
			21 CFR 312.7, 312.6112
			Failure to list additional investigators on 1572
			21 CFR 312.6013
			Subjects receiving simultaneous investigational drugs
			21 CFR 312.6014
			Failure to obtain or document IRB approval
			21 CFR 312.60, 62, 66; 56.10315
			Failure to notify IRB of changes, failure to submit progress reports
			21 CFR 312.6616
			Failure to report adverse drug reactions
			21 CFR 312.64, 312.6617
			Submission of false information
			21 CFR 312.7018
			Other
			n/a19*
			Failure to supervise or personally conduct the clinical investigation
			21 CFR 312.6020*
			Failure to protect the rights, safety, and welfare of subjects
			21 CFR 312.6021*
			Failure to permit FDA access to records
			21 CFR 312.68NG
			Not Given
			n/a* 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.

                                                                                  Content current as of:
      08/03/2022Enforcement Activities | FDA

          
                        Over-the-Counter (OTC) Drugs Branch


                        Unapproved Drugs
          Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
 
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