Create/View Registration

The “Establishment Registration Files” link is used to create and download Establishment Registration files.

Existing Establishment Registration submission files are listed in descending order based on version number.

To create a new Establishment Registration file first populate the “Registration Type” & Effective Date fields, and then click the “Create Registration” button, or the “Create SPL Review File” button to create a Review file to proof your file’s content. Please note that Review files are not saved in SPL Portal, but will be downloaded to your computer automatically. Please save the Review file on your computer for future reference.

For the "Registration Type", the following options are available:

• “Initial Registration” for first time Establishment Registration submissions.
• “Update Registration” for updates to previously submitted Establishments.
• “Create No Change Registration” mainly used to fulfill the FDA’s Annual Drug Firm Establishment Registration Requirement to confirm the Establishment’s registration status with the FDA when there are no reportable changes(no new data to report).
• “Registrant Out of Business” to delist a previously registered Registrant and subsequently all Establishments included in the associated Establishment Registration file.
• “Establishment De-Registration” to delist all previously registered Establishments included in the associated Establishment Registration file, while maintaining the Registrant as an active entity.

The files Version Number(Version No:) is automatically incremented by SPL Portal.

Once the Registration file record has been created, press the download icon to download a zip file which contains the competed Establishment Registration file(in XML format).