CHARGE CODE: LISTERIAFD&C Act Section 402(a)(1)Severity Weight: 10/10

✕ Form FDA 766 Relabeling Ineligible

Adulterated: Bears or contains Listeria monocytogenes

Statutory & CFR Citation: 21 U.S.C. § 342(a)(1) • FDA BAM Chapter 10 (Listeria monocytogenes) • Associated Import Alert 16-39 / Import Alert 99-23

Plain-English Importer Translation:

Ready-to-eat (RTE) seafood, dairy, or botanical extract tested positive or is subject to DWPE for Listeria monocytogenes, a high-fatality foodborne pathogen.

Typical Port Detention Window

25–42 calendar days

Estimated Defense / Lab Cost

$6,000 – $15,500 (Microbiological PLAP + HACCP audit review)

Primary Import Alert Trigger

Import Alert 16-39 / Import Alert 99-23

Form FDA 766 Relabeling / Reconditioning Playbook

NOT ELIGIBLE FOR RELABELING: FDA maintains a strict zero-tolerance policy for Listeria monocytogenes in ready-to-eat (RTE) foods that support growth. Form FDA 766 is only considered if the product can be diverted to a validated thermal lethality process (e.g., canned/cooked industrial ingredient).

Step-by-Step CBP & FDA ITACS Response Sequence:

1Verify cold-chain temperature data loggers from container stuffing to port arrival to ensure detention was not triggered by transit temperature abuse.
2Commission an FDA-accredited laboratory to perform BAM Chapter 10 Listeria monocytogenes testing (25g analytical composites across 10–30 sub-samples).
3Audit the foreign manufacturer's Environmental Monitoring Program (EMP) Zone 1 food-contact swab logs and sanitation SOPs.
4Submit the complete PLAP testimony packet or file for immediate exportation under CBP supervision.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

FDA BAM Chapter 10 detection and enumeration of Listeria monocytogenes across 10 to 30 sub-samples.

Pre-Shipment & Post-Detention Verification Checklist:

Immediately quarantine co-mingled lots and commission AOAC/BAM Listeria monocytogenes cultural confirmation.
Audit cold-chain and post-lethality environmental swab logs (Zones 1-3) from the overseas processing facility.
Coordinate with US customs broker and FDA compliance counsel to hold liquidation while private laboratory packets are reviewed by FDA Division Compliance.

Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for LISTERIA (2)

Soc Trang, Mekong Delta, Vietnam • FEI 3012984019

Mekong Delta Aqua Shrimp Processing Corp.

100/100

Entry #M52-7710294-8 (2026-09-19)Port: Miami

IQF Cooked Peeled & Deveined Tail-On White Shrimp (2lb Retail Bags)

Disposition: Refused & Exported • Value: $184,000

Seafood, Shrimp & Cold-Chain Aquaculture Full Supplier Dossier

Mazatlán, Sinaloa, Mexico • FEI 3013891022

Mazatlan Pacifico Mariscos Congelados S.A. de C.V.

75/100

Entry #M52-7682011-3 (2026-08-07)Port: Miami

Cold-Smoked Yellowfin Tuna Carpaccio Slices (Vacuum Packed)

Disposition: Refused & Exported • Value: $92,400

Seafood, Shrimp & Cold-Chain Aquaculture Full Supplier Dossier

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Full 5-year OASIS refusal history for Mekong Delta Aqua Shrimp Processing Corp. + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Mekong Delta Aqua Shrimp Processing Corp. before you wire your 70% balance payment.

TIER 3 • URGENT US FDA COMPLIANCE COUNSEL DISPATCH (CPL VERIFIED)

Respond-By Deadline Priority Triage

Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

Your Full Name & Role (Required)

Include your name and title (e.g., “Sarah Chen, VP Supply Chain”).

Please provide your full name (at least 2 characters).

Work Email for 24h Legal Memo (Required)

Used strictly to deliver your conflict-free 24h FDA detention evaluation.

Please enter a valid corporate email address.

Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

Please enter a valid URL starting with https:// or http://.

CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3012984019) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

Select the FDA District / Port holding the cargo.

Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

🔒 Confidential submission • Zero upfront cost for 24h detention evaluation • Matched with licensed US FDA / Customs attorneys.

Charge Code LISTERIA FAQ

What does FDA Charge Code LISTERIA (FD&C Act Section 402(a)(1)) mean on a Notice of FDA Action?

Adulterated: Bears or contains Listeria monocytogenes. In plain English: Ready-to-eat (RTE) seafood, dairy, or botanical extract tested positive or is subject to DWPE for Listeria monocytogenes, a high-fatality foodborne pathogen.