FDA Import Alert Response

FDA IMPORT ALERT / DETENTION RESPONSE

RESPONSE TO NOTICE OF DETENTION AND HEARING

PART 1: SHIPMENT AND DETENTION INFORMATION

1.1 Detention Notice Information

1.2 Response Deadline

Note: FDA allows 10 business days from detention; notices typically specify 20 calendar days to account for mailing time.

1.3 Charged Violations

Violation(s) cited on Notice of Detention:

PART 2: PARTY INFORMATION

2.1 Importer of Record

2.2 Consignee (if different from Importer)

2.3 Foreign Manufacturer/Shipper

2.4 Customs Broker (if applicable)

2.5 Authorized Representative

I, [________________________________], am authorized to respond on behalf of:

☐ Consignee
☐ Owner
☐ Importer of Record

Authorization documentation attached: ☐ Yes

PART 3: PRODUCT INFORMATION

3.1 Product Details

3.2 Shipment Details

3.3 Prior Shipments (if applicable)

PART 4: IMPORT ALERT STATUS

4.1 Import Alert Information

Is the product/firm subject to Detention Without Physical Examination (DWPE)?

☐ Yes - Import Alert Number: [________________________________]
☐ No
☐ Unknown

If Yes:

4.2 Type of Response

This response is submitted to:

☐ Overcome appearance of violation for current shipment (provide evidence below)
☐ Request removal from Import Alert (Red List to Green List petition)
☐ Both - Release current shipment AND request removal from Import Alert

PART 5: RESPONSE TO CHARGES

5.1 Response Cover Letter

[COMPANY LETTERHEAD]

Date: [__/__/____]

Food and Drug Administration
[________________________________]
[________________________________]
[________________________________]

Re: Response to Notice of Detention and Hearing
Entry Number: [________________________________]
Product: [________________________________]
FDA District: [________________________________]

Dear Sir or Madam:

This letter constitutes [________________________________]'s formal response to the Notice of Detention and Hearing dated [__/__/____] regarding the above-referenced entry.

We respectfully request that FDA release the detained shipment based on the evidence and testimony provided herein, which demonstrates that the product is not in violation of the Federal Food, Drug, and Cosmetic Act.

[INTRODUCTION PARAGRAPH - Briefly summarize why the product should be released]

[________________________________]

5.2 Detailed Response to Each Charge

CHARGE 1:

FDA Citation: [________________________________]

Our Response:

[________________________________]

Evidence Provided:
☐ Certificate of Analysis (COA)
☐ Test results from accredited laboratory
☐ Manufacturing records
☐ HACCP/Food Safety records
☐ Third-party audit report
☐ Certificates (organic, kosher, etc.)
☐ Other: [________________________________]

CHARGE 2:

FDA Citation: [________________________________]

Our Response:

[________________________________]

Evidence Provided:
☐ Certificate of Analysis (COA)
☐ Test results from accredited laboratory
☐ Manufacturing records
☐ HACCP/Food Safety records
☐ Third-party audit report
☐ Other: [________________________________]

CHARGE 3:

FDA Citation: [________________________________]

Our Response:

[________________________________]

Evidence Provided:
☐ [________________________________]

5.3 Reconditioning Request (if applicable)

☐ Not requesting reconditioning
☐ Requesting permission to recondition product

Proposed Reconditioning Method:

Note: Reconditioning must be completed within 90 days unless extension granted.

PART 6: SUPPORTING DOCUMENTATION

6.1 Evidence Checklist

Attach the following documentation as applicable:

☐ Certificates of Analysis (COA) from accredited laboratory
- Lab name: [________________________________]
- Lab accreditation: [________________________________]
- Test date: [__/__/____]

☐ Laboratory Test Results addressing specific violation
- Test method: [________________________________]
- Results: [________________________________]

☐ Manufacturing Records
- Batch/production records
- Process validation

☐ Hazard Analysis / Food Safety Plan
- HACCP plan
- Preventive controls documentation

☐ Third-Party Audit Report
- Audit firm: [________________________________]
- Audit date: [__/__/____]
- Audit score/findings: [________________________________]

☐ Supplier/Manufacturer Documentation
- Food safety certifications (SQF, BRC, FSSC 22000, etc.)
- Registration documentation
- Facility audit reports

☐ Labeling Documentation
- Current labels
- Label review/approval records
- Ingredient specifications

☐ Import History
- Prior entry documentation
- Previous release records

☐ Corrective Action Documentation (if firm was previously cited)
- CAPA records
- Evidence of corrective measures

☐ Other Evidence
- [________________________________]
- [________________________________]

6.2 Document Index

PART 7: PETITION FOR REMOVAL FROM IMPORT ALERT

7.1 Removal Petition (if applicable)

☐ Not petitioning for removal from Import Alert at this time
☐ Requesting removal from Import Alert (complete below)

Petition Submitted To: [email protected]

7.2 Evidence of Corrective Actions

Describe corrective actions implemented to address the reason for Import Alert listing:

[________________________________]
[________________________________]
[________________________________]

7.3 Consecutive Compliant Shipments

FDA typically requires 5 consecutive shipments without violation:

7.4 Third-Party Certification/Verification

☐ Third-party food safety audit attached
☐ GFSI-recognized certification attached
☐ Accredited laboratory testing program established

PART 8: REQUEST FOR EXTENSION (if needed)

8.1 Extension Request

☐ Not requesting extension
☐ Requesting extension to respond

Current "Respond By" Date: [__/__/____]

Requested New Deadline: [__/__/____]

Reason for Extension Request:

[________________________________]

Note: Extension request must be submitted within the original timeframe and must provide reasonable basis.

PART 9: RESPONSE SUBMISSION

9.1 Submission Details

Response Submitted To:

Submission Method:

☐ Electronic (email)
☐ Mail
☐ Fax
☐ Hand delivery

Date Submitted: [__/__/____]

9.2 Confirmation

☐ Confirmation of receipt obtained
☐ FDA case number: [________________________________]

PART 10: FOLLOW-UP ACTIONS

10.1 FDA Response

10.2 If Shipment Refused

Refused shipment must be:

☐ Exported under CBP and FDA supervision within 90 days
☐ Destroyed under CBP and FDA supervision within 90 days

10.3 Appeal Options

If dissatisfied with FDA decision:

☐ Request supervisory review
☐ File formal dispute with FDA Division Director
☐ Consider legal action

PART 11: PREVENTIVE MEASURES

11.1 Future Import Compliance

To prevent future detentions, implement:

☐ Pre-shipment testing program
☐ Supplier qualification program
☐ Third-party audits of foreign suppliers
☐ Enhanced documentation procedures
☐ Prior notice accuracy verification
☐ Other: [________________________________]

11.2 Communication with Foreign Supplier

☐ Supplier notified of detention
☐ Corrective action requested from supplier
☐ Supplier response received
☐ Updated supplier agreement/controls

CERTIFICATION

I certify that the information provided in this response is true, accurate, and complete to the best of my knowledge.

Signature: ________________________________________

Printed Name: [________________________________]

Title: [________________________________]

Company: [________________________________]

Date: [__/__/____]

IMPORTANT REGULATORY NOTES

Response Timeline

• Standard Response Period: 10 business days from detention (20 calendar days typically stated on notice)
• Extension: May be requested within the original timeframe with reasonable basis
• Failure to Respond: FDA may issue refusal of admission

Evidence Requirements

• Submit credible evidence that product does not violate FD&C Act
• Laboratory testing should be from accredited laboratories
• Documentation must be specific to the detained shipment

Refusal Consequences

• Refused shipments must be exported or destroyed within 90 days
• Refusal is a final decision (cannot be rescinded unless issued in error)
• May impact future import entries and Import Alert status

Removal from Import Alert

• Submit petition to: [email protected]
• Demonstrate corrective actions
• Typically requires 5 consecutive compliant shipments
• Reference FDA Regulatory Procedures Manual Chapter 9-8

SOURCES AND REFERENCES

• FDA Import Alert System: https://www.accessdata.fda.gov/cms_ia/ialist.html
• FDA Detention and Hearing: https://www.fda.gov/industry/fda-import-process/detention-hearing
• FDA Regulatory Procedures Manual Chapter 9
• 21 CFR Part 1 Subpart I - Prior Notice of Imported Food

This template is provided for informational purposes only. Import detention responses are time-sensitive and require specific evidence. Consult with an FDA import specialist or customs attorney for specific guidance.