Purpose

To outline the steps to take when serialized product is physically received, but the corresponding EPCIS data has not been received or is incomplete, in accordance with DSCSA compliance requirements.

When to Use This Guideline

This applies when:

• Serialized product arrives at the facility and no EPCIS file is received (No file located in EPCIS orders or EPCIS history)
  
  
• EPCIS file is received but missing relevant product data (e.g., serial numbers, GTINs)
  

Step-by-Step Response Process

1.  Do Not Immediately Accept into Inventory
   • Hold the product in a designated quarantine or non-sellable status.
     
     
   • Clearly label the product as “Pending Data Verification.”
     
     
2. Check for Data Receipt Issues
   • Review your inbound data system or EPCIS repository:
     • Was a file received but failed validation? 
       
       
     • Is there no file in the EPCIS Order or EPCIS History section?
       
       
     • Is the data delayed from the trading partner?
       
       
3. Notify Internal Stakeholders
   
   
4. Contact the Trading Partner
   • Send a standardized inquiry requesting the missing EPCIS file. Include:
     • PO number
       
       
     • Shipment ID / ASN (if available)
       
       
     • Description of the product received
       
       
     • Data and time of the receipt
       
       
   • Sample message:
     
     "We received serialized product under PO [12345] on [Date], but we have not received the corresponding EPCIS data. Can you please confirm whether the data has been sent, and if not, resend it?"
     
     
5. Allow a Grace Period
   • Set a standard grace period (e.g., 3 business days) to allow the trading partner to resend or correct the file.
     
     
6. Escalate if No Resolution
   • If no data is received after the grace period:
     • Escalate to compliance and procurement leads
       
       
     • Evaluate whether to accept product under exception handling
       
       
     • Document the incident for audit trail
       
       
7. Log the Incident
   • Record all the details in a DSCSA compliance log, including:
     • Date of product receipt
       
       
     • Trading partner contacted
       
       
     • Follow-up actions taken
       
       
     • Final resolution