2026 CBP ACE & FDA OASIS Enforcement Update: MoCRA Cosmetic FEI & QMSR Device 510(k) Affirmation of Compliance cross-checks are active at Los Angeles, Newark, Miami & Savannah ports.
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CHARGE CODE: SALMONELLAFD&C Act Section 402(a)(1)Severity Weight: 10/10
✕ Form FDA 766 Relabeling Ineligible

Adulterated: Appears to contain Salmonella, a poisonous and deleterious substance

Statutory & CFR Citation: 21 U.S.C. § 342(a)(1) • FDA Bacteriological Analytical Manual (BAM) Chapter 5 • Associated Import Alert 99-19 / Import Alert 16-81 / Import Alert 28-02
Plain-English Importer Translation:

FDA microbiological sampling or Import Alert 99-19 / 16-81 surveillance flagged the food, spice, or aquaculture shipment for Salmonella spp. contamination.

Typical Port Detention Window
24–40 calendar days
Estimated Defense / Lab Cost
$5,500 – $14,000 (Accredited 30/60-sub lab packet + compliance counsel)
Primary Import Alert Trigger
Import Alert 99-19 / Import Alert 16-81 / Import Alert 28-02

Form FDA 766 Relabeling / Reconditioning Playbook

NEVER ELIGIBLE FOR RELABELING: Pathogen contamination cannot be cured by labeling. Reconditioning via Form FDA 766 requires a validated kill-step (e.g., commercial irradiation, steam sterilization, or thermal cooking) at an FDA-approved domestic reconditioning facility.

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

  1. 1If the shipment is detained under DWPE (Import Alert 16-81, 28-02, or 99-19) without an FDA positive sample yet, immediately hire an approved private sampler to collect 15, 30, or 60 sub-samples per BAM Chapter 5.
  2. 2Submit the full Private Laboratory Analytical Package (PLAP) via ITACS before the Respond-By Date (request a 14-day extension if culture enrichment is underway).
  3. 3If FDA or private lab testing confirms Salmonella positivity, evaluate whether an approved thermal/steam kill-step reconditioning protocol under Form FDA 766 is economically viable (typically only for bulk spices >$75,000).
  4. 4Otherwise, execute supervised export or destruction and initiate a 5-shipment Green List / Red List removal petition for the overseas plant.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

FDA BAM Chapter 5 Salmonella cultural/PCR method across 15 (Category III), 30 (Category II), or 60 (Category I) sub-samples.

Pre-Shipment & Post-Detention Verification Checklist:
  • Engage an FDA-recognized private laboratory for BAM Chapter 5 Salmonella composite composite testing (15 to 60 subsamples depending on lot risk).
  • Do not attempt Form FDA 766 relabeling; pathogen-adulterated food requires an approved heat-treatment/irradiation reconditioning protocol or export/destruction.
  • Prepare a Root Cause Analysis (RCA) and 5 consecutive non-violative commercial shipment packets to petition off Import Alert Red List.
Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for SALMONELLA (2)

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Charge Code SALMONELLA FAQ

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

Adulterated: Appears to contain Salmonella, a poisonous and deleterious substance. In plain English: FDA microbiological sampling or Import Alert 99-19 / 16-81 surveillance flagged the food, spice, or aquaculture shipment for Salmonella spp. contamination.

Can a shipment detained for SALMONELLA be released via Form FDA 766 relabeling?

NEVER ELIGIBLE FOR RELABELING: Pathogen contamination cannot be cured by labeling. Reconditioning via Form FDA 766 requires a validated kill-step (e.g., commercial irradiation, steam sterilization, or thermal cooking) at an FDA-approved domestic reconditioning facility. Final authorization always rests with the reviewing FDA District Import Compliance Office.