Food and Drug Administration (FDA)

Status

If this PGA is non-applicable, select the status to Disclaimed, followed by a Disclaim Reason Code.

Disclaim Reason Code

If the PGA is non-applicable, select Disclaimed for the Status and then you must also select a disclaim reason code. This provides a clear and explicit flagging for these disclaim situations.

Description

The Description field has an icon with a blue arrow that you can click to populate the PGA Description field with whatever is listed in the Commercial Description in the main product screen. It is optional to use this feature, and a given PGA description does not necessarily need to match the main product Commercial Description.

Category Code

Select the category code from the drop-down list. This supports the U.S. Customs PGA requirements related to ACE.

Sub-Category Code

Select the sub-category code from the drop-down list. This supports the U.S. Customs PGA requirements related to ACE.

Intended Use Code

Select the intended use code from the drop-down list. This supports the U.S. Customs PGA requirements related to ACE.

Country of Origin

Select the origin country of the product from drop-down list.

This is a required field.

Product Code

FDA code for this product. Enter the code in the format "##XXX##". Where # represents numbers and X represents letters. For example, 13HAK37.
Website is linked to the Product Code Builder. This can be used to select the Product Code on the basis of various search criteria like industry, product name and code.

Item Type

Select the item type from the drop-down list. This supports the U.S. Customs PGA requirements related to ACE.

Method Stored by

Method used for storing the product.  Select from the drop-down list with the following values:

• Ambient

• Frozen

• Refrigerated

Brand

Brand name of the product.

Affirmation of Compliance Codes (AOC) Type/Qualifiers

Defines an FDA compliance code that applies to this product.

Click Add New Compliance Type to add additional types.

Compliance Code

Specific commodity/condition code. Must be a valid FDA compliance.

Compliance Code Qualifier

If a compliance code is used, it must have a qualifier.

Container DIMS

Cylindrical, W/Dia,  L, H

Dimensions for an individual package for this product. The information is populated from Standard Package details if available. Includes three dimensions: width or diameter, height, and length. Unit of measure is always inches (IN).

Select the Cylindrical check box if the package is cylindrical.

Storage Class

Select the storage class from the drop-down list. This supports the U.S. Customs PGA requirements related to ACE.

Contact Name

Contact name of the importer.

Contact Number

Contact phone number of the importer.

Notes

Space for notes.

Packaging

Describes packaging details of this product for the FDA.

Click Add New Package Detail to add additional packaging information.

Quantity

Quantity for this package configuration.

Unit of Measure

FDA unit of measure for this packaging configuration. Must be a valid FDA unit of measure.

Base Unit

Quantity

Base quantity.

Unit of Measure

Base unit of measurement.

Ingredient

Add ingredient information such as Name, Active, Percent, Quantity and UOM. Click Add New Ingredient to add additional ingredient information.

Trade Partners

Click Add New Partner to add additional trade partners.

Code

Enter the supplier/vendor's Trade Partner ID by entering the reference or clicking to select.

Role

Select the role of the Trade Partner from the drop-down list.