| Title: | How to Resolve FDA Rejections |
|---|---|
| Date: | 2018-06-04 |
| To: | abi |
| Links: | previous, original, next |
FDA has received requests for clarifications on the process for resolving FDA Rejections. If an entry has been rejected by FDA, determine the CBP entry status and follow the below instructions to resolve:
If an entry is rejected by FDA before arrival and release:
• An SE may be completely replaced:
o Filer can Replace the entry (using ‘update action code’ = R, in the SE transaction), as often as desired, without CBP approval.
• Or, Filer can file a CA transaction if they only need to change PGA data (a CA does not need approval by CBP).
If an entry is rejected by FDA and it has been arrived but not released:
• An SE must go through a correction:
o All Filer submissions of type R, automatically become ‘requests’ and these must be approved by CBP.
o (NOTE: the first entry submission has an action code = A. After that, unless the filer is cancelling or doing an update, the action code = R)
• Or, Filer can file a CA transaction if they only want to change PGA data (a CA does not need approval by CBP).
If an entry is rejected by FDA after arrival and release:
• Up to 10 days after arrival and release:
o If only changing PGA data, file a CA
o Filer must Cancel the existing entry and submit a new entry if changing anything other than PGA message set data.
• Up to 15 days after arrival and release:
o Filer can submit an Update (using ‘update action code’ = U, in the SE transaction), only to update the allowed bill data
o Cannot change any PGA (or other CBP) data on an update (U).
As a reminder, corrections for FDA entries are only allowed when the FDA status is “Rejected” or if CBP has not sent the data to FDA because it is more than 5 days before the anticipated date and time of arrival entered in the PG30.
To understand why an entry was rejected, visit https://www.fda.gov/downloads/ForIndustry/ImportProgram/EntryProcess/ImportSystems/UCM516615.pdf.
For more information about specific FDA rejections, contact ACE_Support@fda.hhs.gov.
For more information about Update, Replace, and CA Transactions, contact your CBP client representative.