January 2023

FDA Division of Import Systems

Solutions

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FDA ITACS Public Statuses

One of the features of FDA’s Import Trade Auxiliary Communication System 

(ITACS) is the availability of what FDA has designated as statuses that can be 

displayed to the public. The following are statuses corresponding with many of 

the FDA admissibility decisions and activities used to record interim field and 

compliance actions which are recorded in FDA’s Import system. They are meant 

to augment the 15 electronic statuses which are currently transmitted via the 

FDA/Customs Interface, as well as the larger set currently included in Notices of 

FDA Action. Some of the status text displayed as Public Statuses in ITACS have 

been modified to be more easily understood.

Audit Sample Received by FDA Lab

Compliance Response to Trade Communication - Please Refer to Notice 

of FDA Action

Detained - Refer to Notice of FDA Action for Violation Charges

Detained Without Physical Exam - Refer to Notice of FDA Action for

Violation Charges

Detained May be Destroyed - Refer to Notice of FDA Action for Violation 

Charges

Detention Withdrawn - Pending Further FDA Compliance Review

Document Accepted

Document Rejected - Attempt to Resubmit

Document Submitted

Duplicate Entry has been closed

Duplicate Line has been closed

Entry Closed - No Further FDA Action

Entry Deficient - Please Refer to Notice of FDA Action for Details

Entry Documents Required

Entry Documents Required - Notify FDA of Location for FDA 

Examination

Extension Granted - Refer to Notice of FDA Action for Response Deadline

Extension Request Denied
January 2023

FDA Division of Import Systems

Solutions

Page 2 of 5

Extension Request Received

FDA Audit Lab Analysis Completed. FDA Compliance Staff are reviewing

the line to determine admissibility. This status will be updated when that 

determination is made, and the final admissibility decision for this line

will be reflected in the Notice of FDA Action generated after that decision 

is recorded by FDA.

FDA Audit Lab Analysis in Process

FDA Audit Sample Collected

FDA Examination Completed

FDA Examination Pending

FDA Lab Analysis Completed. FDA Compliance Staff are reviewing the 

line to determine admissibility. This status will be updated when that 

determination is made, and the final admissibility decision for this line will

be reflected in the Notice of FDA Action generated after that decision is

recorded by FDA.

FDA Lab Analysis in Process

FDA Reconditioning Lab Analysis Completed. FDA Compliance Staff are 

reviewing the line to determine admissibility. This status will be updated

when that determination is made, and the final admissibility decision for 

this line will be reflected in the Notice of FDA Action generated after that

decision is recorded by FDA.

FDA Reconditioning Lab Analysis in Process

FDA Reconditioning Sample Collected

FDA Sample Collected

Further Reconditioning Approved

Goods Were Not Available for FDA Examination - Notify FDA When

Available

Held Pending Receipt of Requested Information - See Notice of FDA 

Action for Details

Hold All Designated Lines

Hold All Designated Lines - Do Not Devan

Hold All Designated Lines - Do Not Devan – Entry Documents Required

Hold All Designated Lines - Do Not Devan – Entry Documents Required -

Notify FDA of Location for Examination
January 2023

FDA Division of Import Systems

Solutions

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Hold All Designated Lines - Do Not Devan - Notify FDA of Location for

Examination

Hold All Designated Lines – Entry Documents Required

Hold All Designated Lines – Entry Documents Required - Notify FDA of

Location for Examination

Hold All Designated Lines - Notify FDA of Location for FDA Examination

Hold Designated Lines

Hold Designated Lines -Entry Documents Required

Hold Designated Lines -Entry Documents Required - Notify FDA of

Location for FDA Examination

Hold Designated Lines - Notify FDA of Location for FDA Examination

Hold Line – Notify FDA of Location for FDA Examination

Hold Pending Analysis Results of Sampled Line

Information Requested - See Notice of FDA Action for Details

Interface Error Contact FDA

Line Availability Received

Line Availability Received, FDA Examination Pending

Line Closed

Line has been cancelled by CBP

Line Split Due to Multiple Products Identified - See Notice of FDA Action 

for Details. Review ITACS for Status of Split Lines.

Mail/Baggage Entry Destroyed

Mail/Baggage Entry Partially Released, Partially Destroyed

Mail/Baggage Entry Partially Returned to Sender, Partially Destroyed

Mail/Baggage Entry Released

Mail/Baggage Entry Returned to Sender

May Proceed Rescinded - Hold for Further Information from FDA

May Proceed Without FDA Examination
January 2023

FDA Division of Import Systems

Solutions

Page 4 of 5

Non-FDA Lab Rejected - Additional Private Lab Submission Not Allowed

Non-FDA Analysis Rejected following Audit Sample - No Resubmission

Allowed

Non-FDA Analysis Rejected following Audit Sample - Resubmission

Allowed

Non-FDA Lab Rejected

Non-FDA Lab Rejected - Resubmission Allowed

Non-FDA Lab Report Received

Non-FDA Lab Under Review

Notify FDA of Location for FDA Examination

Partial Refusal - Inform FDA After Export or Destruction of Refused

Portion

Partial Refusal - Inform FDA Before Export or Destruction of Refused

Portion

Pending Review by FDA Compliance Staff

Private Laboratory Analysis Confirms Product is Violative

Proof of Export or Destruction Received

Reconditioned Materials Released

Reconditioning Completion Notification Received by FDA

Reconditioning Request (FDA-766) Denied

Reconditioning Request (FDA-766) Under Review

Reconditioning Request Approved - FDA Supervision Not Required

Reconditioning Request Approved - Contact FDA to Arrange Supervision

Reconditioning Request Conditionally Approved

Reconditioning Request Conditionally Approved - Contact FDA to

Arrange Supervision

Reconditioning Request Conditionally Approved - Refer to Notice of FDA 

Action for Conditions

Reconditioning Request Denied - Resubmission Allowed

Reconditioning Request Incomplete - Resubmission Allowed
January 2023

FDA Division of Import Systems

Solutions

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Reconditioning Supervision Waived - Contact FDA when Reconditioning 

is Complete

Reconditioning Unsatisfactory

Reconditioning Unsuccessful - Resubmission Allowed

Refusal Follow-up Completed

Refusal Rescinded - Product Still Detained

Refused Admission by FDA and Returned to Sender

Refused Inform FDA After Export or Destruction

Refused Inform FDA Before Export or Destruction

Release Rescinded - Hold for Further Information from FDA

Released

Released With Comment - Future Violative Shipments May Be Detained -

Refer to Notice of FDA Action for More Information.

Sample Received by FDA Lab

Submission Under Technical Review

Submit Entry Documents to FDA (Invoice, B/L, CBP Entry Document)

Submit Proof of Export or Destruction to FDA (CBP Form and On-Board 

shipping records)