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: FILTHFD&C Act Section 402(a)(3)Severity Weight: 9/10
✕ Form FDA 766 Relabeling Ineligible

Adulterated: Consists in whole or in part of filthy, putrid, or decomposed substance

Statutory & CFR Citation: 21 U.S.C. § 342(a)(3) • 21 CFR § 110.110 (Defect Action Levels) • Associated Import Alert 28-02 / Import Alert 99-39
Plain-English Importer Translation:

FDA port inspectors or laboratory analysis detected insect fragments, rodent hair, mold, or decomposition in the shipment.

Typical Port Detention Window
21–35 calendar days
Estimated Defense / Lab Cost
$4,500 – $9,500 (including private lab packet + DWPE petition)
Primary Import Alert Trigger
Import Alert 28-02 / Import Alert 99-39

Form FDA 766 Relabeling / Reconditioning Playbook

NOT ELIGIBLE for label-only reconditioning. Form FDA 766 may only be approved for physical sorting, sifting, or industrial cleaning if the importer proves contamination is localized and removable without blending adulterated lots.

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

  1. 1Obtain the FDA Notice of Action specifying exact Macroanalytical Procedures Manual (MPM) sub-sample defect counts (e.g., insect fragments per 50g).
  2. 2Retain an ISO 17025 FDA-recognized laboratory to sample 12–18 representative sub-samples before filing a testimony deadline extension.
  3. 3If defect counts exceed FDA Defect Action Levels (DALs), do NOT propose blending; file CBP Form 3499 for immediate exportation to avoid warehouse demurrage.
  4. 4To remove the supplier from DWPE Red List, compile 5 consecutive non-violative commercial entries plus a verified factory integrated pest management (IPM) audit.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

FDA Macroanalytical Procedures Manual (MPM) / AOAC Official Method 969.41 or 975.49 light & heavy filth flotation across 6 to 18 sub-samples.

Pre-Shipment & Post-Detention Verification Checklist:
  • Commission an accredited independent 3rd-party lab micro-filth analysis within 10 business days of Notice of FDA Action.
  • Submit a Petition for Removal from Detention Without Physical Examination (DWPE) after 5 consecutive clean shipments.
  • Audit factory HACCP sanitation records before wiring balance payments.
Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for FILTH (4)

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  • Full 5-year OASIS refusal history for Kochi Malabar Spice & Oleoresins Pvt. Ltd. + 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 Kochi Malabar Spice & Oleoresins Pvt. Ltd. before you wire your 70% balance payment.

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Charge Code FILTH FAQ

What does FDA Charge Code FILTH (FD&C Act Section 402(a)(3)) mean on a Notice of FDA Action?

Adulterated: Consists in whole or in part of filthy, putrid, or decomposed substance. In plain English: FDA port inspectors or laboratory analysis detected insect fragments, rodent hair, mold, or decomposition in the shipment.

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

NOT ELIGIBLE for label-only reconditioning. Form FDA 766 may only be approved for physical sorting, sifting, or industrial cleaning if the importer proves contamination is localized and removable without blending adulterated lots. Final authorization always rests with the reviewing FDA District Import Compliance Office.