# DWPERadar 2026 — Overseas Supplier FDA Import Alert (DWPE), OASIS Refusal & Compliance Dossiers

> Cross-linking 5-year FDA Import Alerts (DWPE Red/Green List), OASIS Refusals, Warning Letters, and Recalls into high-information-gain Supplier Credit Dossiers, Form FDA 766 relabeling playbooks, and QMSR/MoCRA compliance briefings.

Canonical URL: https://feilookup.com
Last Verified: 2026-11-13

## Verified Capabilities & Facts
- Covers 12 deduplicated overseas manufacturing facilities across China, India, South Korea, Vietnam, Mexico, and Italy with 10-digit FEI and 9-digit DUNS crosswalks.
- Computes a 0–100 Composite Risk Score combining 5-year Import Refusals, active CDER/CFSAN/CDRH Warning Letters (+25 pts), and Class I/II/III Recalls (+18 pts).
- Downloadable cleaned CSV and Excel datasets at /datasets/dwperadar-2021-2026-all-categories.csv (.xls) plus live JSON/CSV export at /api/export.
- All 8 major FDA Charge Codes decoded with Form FDA 766 relabeling eligibility: FILTH, UNAPPROVED_NEW_DRUG, UNSAFE_COLOR, NO_510K, NUTRITIONAL_LABELING, SALMONELLA, LISTERIA, INSANITARY_CONDITIONS.

## Scope Boundaries & Exclusions
- DWPERadar aggregates historical public FDA Import Alert (DWPE) & OASIS/openFDA enforcement records for informational supplier due diligence only—it is not a US Customs broker or licensed legal counsel.
- Passing a clean supplier lookup or holding a third-party ISO 13485 certificate does not guarantee port clearance under FDA QMSR (effective Feb 2, 2026) or MoCRA.
- Form FDA 766 bonded relabeling eligibility is statutory guidance only; actual reconditioning permission is granted case-by-case by the reviewing FDA District Office.

## 2026 Regulatory Guides (QMSR, MoCRA, DWPE / Form 766)

- [FDA QMSR 2026 (21 CFR Part 820) & ISO 13485:2016: Medical Device Import Detention & 510(k) Checklist](https://feilookup.com/guides/fda-qmsr-2026-iso-13485-compliance): Effective February 2, 2026, the FDA Quality Management System Regulation (QMSR) overhauled 21 CFR Part 820 by incorporating ISO 13485:2016 by reference and replacing legacy QSIT inspections with Compliance Program 7382.850. Having a 510(k) clearance alone does not shield an overseas factory from warning letters or port holds if post-clearance manufacturing controls fail QMSR audits.
- [MoCRA Cosmetics Facility Registration, Product Listing & Port Import Refusal Guide (2026)](https://feilookup.com/guides/mocra-cosmetics-fda-registration-import-refusal): Under the Modernization of Cosmetics Regulation Act (MoCRA), overseas cosmetics facilities must hold active FDA registration (FEI) and Responsible Person product listings, maintain written safety substantiation, and print adverse event reporting contacts on labels. Crucial warning: the FDA does NOT pre-approve cosmetics or issue pre-market 'compliance certificates' for foreign shipments—port surveillance checks digital listings and packaging claims in real time.
- [FDA Import Alert DWPE (Red vs. Green List) & Form FDA 766 Bonded Relabeling Timeline](https://feilookup.com/guides/dwpe-green-list-removal-form-fda-766-relabeling): Once an overseas supplier lands on an FDA Import Alert Red List (DWPE), CBP automatically detains every future entry without physically sampling it first—shifting full testing and compliance proof onto the importer. Form FDA 766 authorizes bonded relabeling ONLY for correctable technical labeling violations (such as § 403(q) nutrition panels or non-compliant claims); pathogen, filth, or insanitary violations (SALMONELLA, LISTERIA, FILTH) require private lab testing under strict protocols or result in export/destruction.

## Audited Overseas Supplier Compliance Dossiers

- [Guangzhou Lumi-Derma Biotech Co., Ltd. (FEI 3018492011 • China) — Risk Score 100/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/guangzhou-lumi-derma-biotech): Red List — Import Alert 66-41 & 53-06 (DWPE Active). 3 5-yr refusals at Los Angeles, 1 warning letters, 1 recalls.
- [Incheon K-Beauty Cosmeceuticals Inc. (FEI 3021904812 • South Korea) — Risk Score 21/100 [MODERATE]](https://feilookup.com/supplier/incheon-k-beauty-cosmeceuticals): Green List — MoCRA Registered (Occasional Claim Holds). 1 5-yr refusals at Los Angeles, 0 warning letters, 0 recalls.
- [Kochi Malabar Spice & Oleoresins Pvt. Ltd. (FEI 3011094823 • India) — Risk Score 100/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/kochi-malabar-spice-oleoresins): Red List — Import Alert 28-02 & 99-19 (Mandatory 30-Sub Salmonella PLAP). 3 5-yr refusals at Newark, 1 warning letters, 1 recalls.
- [Dak Lak Highland Botanicals & Cassia JSC (FEI 3019823401 • Vietnam) — Risk Score 57/100 [HIGH]](https://feilookup.com/supplier/dak-lak-highland-botanicals-jsc): Red List — Import Alert 99-19 (Cassia Cinnamon & Star Anise). 2 5-yr refusals at Savannah, 0 warning letters, 1 recalls.
- [Shenzhen MedOptic Photon Technology Co., Ltd. (FEI 3016729104 • China) — Risk Score 100/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/shenzhen-medoptic-photon-tech): Red List — Import Alert 89-08 (Device Without Cleared 510(k)). 3 5-yr refusals at Los Angeles, 1 warning letters, 1 recalls.
- [Tijuana Baja MedTech Assemblies S.A. de C.V. (FEI 3014920188 • Mexico) — Risk Score 24/100 [MODERATE]](https://feilookup.com/supplier/tijuana-baja-medtech-assemblies): Green List — Active FURLS Registration & 510(k) Contract Maquiladora. 1 5-yr refusals at Los Angeles, 0 warning letters, 0 recalls.
- [Mekong Delta Aqua Shrimp Processing Corp. (FEI 3012984019 • Vietnam) — Risk Score 100/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/mekong-delta-aqua-shrimp-processing): Red List — Import Alert 16-81 & 16-39 (Salmonella & Listeria DWPE). 3 5-yr refusals at Miami, 1 warning letters, 1 recalls.
- [Ahmedabad Sterile Ophthalmics & Pharma Ltd. (FEI 3015092811 • India) — Risk Score 100/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/ahmedabad-sterile-ophthalmics-pharma): Red List — Import Alert 66-40 (cGMP Sterility Non-Conformity). 3 5-yr refusals at Newark, 1 warning letters, 1 recalls.
- [Xiamen NutriGummy Biosciences Co., Ltd. (FEI 3017610293 • China) — Risk Score 76/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/xiamen-nutrigummy-biosciences): Red List — Import Alert 54-16 & 99-20 (Supplement Facts & Claims). 3 5-yr refusals at Los Angeles, 1 warning letters, 0 recalls.
- [Milano Nutraceutica Liposomal S.r.l. (FEI 3020192844 • Italy) — Risk Score 24/100 [MODERATE]](https://feilookup.com/supplier/milano-nutraceutica-liposomal-srl): Yellow List — EU-to-US Nutrition Panel Surveillance. 2 5-yr refusals at Newark, 0 warning letters, 0 recalls.
- [Mazatlan Pacifico Mariscos Congelados S.A. de C.V. (FEI 3013891022 • Mexico) — Risk Score 75/100 [CRITICAL_IMPORT_ALERT]](https://feilookup.com/supplier/mazatlan-pacifico-mariscos-congelados): Red List — Import Alert 16-18 & 16-39 (Decomposition & Listeria). 2 5-yr refusals at Miami, 0 warning letters, 1 recalls.
- [Osong BioPharma Isotonic Labs Co., Ltd. (FEI 3022819044 • South Korea) — Risk Score 33/100 [MODERATE]](https://feilookup.com/supplier/osong-biopharma-isotonic-labs): Yellow List — OTC Monograph Drug Facts & NDC Listing Verification. 2 5-yr refusals at Savannah, 0 warning letters, 0 recalls.

## FDA Regulated Product Categories (Detention Leaderboard)

- [Cosmetics, Serums & MoCRA Skincare (Industry Code 53 (Cosmetics))](https://feilookup.com/category/cosmetics-skincare): 5-Yr Detention Rate: 14.8%, Avg Port Hold: 19 days. Top charges: UNAPPROVED_NEW_DRUG, UNSAFE_COLOR, INSANITARY_CONDITIONS.
- [Dietary Supplements, Nutraceuticals & Botanicals (Industry Code 54 (Vitamins, Minerals & Unconventional Diets))](https://feilookup.com/category/dietary-supplements): 5-Yr Detention Rate: 18.4%, Avg Port Hold: 23 days. Top charges: NUTRITIONAL_LABELING, UNAPPROVED_NEW_DRUG, INSANITARY_CONDITIONS.
- [Class I/II Medical, Dental & Aesthetic Devices (Industry Code 73–89 (Medical & Aesthetic Devices))](https://feilookup.com/category/medical-devices): 5-Yr Detention Rate: 21.2%, Avg Port Hold: 28 days. Top charges: NO_510K, UNAPPROVED_NEW_DRUG, INSANITARY_CONDITIONS.
- [Seafood, Shrimp & Cold-Chain Aquaculture (Industry Code 16 (Fishery & Seafood Products))](https://feilookup.com/category/seafood-aquaculture): 5-Yr Detention Rate: 24.6%, Avg Port Hold: 26 days. Top charges: SALMONELLA, LISTERIA, FILTH.
- [Whole Spices, Culinary Herbs & Botanical Extracts (Industry Code 28 (Spices, Flavors & Salts))](https://feilookup.com/category/spices-botanicals): 5-Yr Detention Rate: 29.5%, Avg Port Hold: 31 days. Top charges: SALMONELLA, FILTH, NUTRITIONAL_LABELING.
- [Ophthalmic Drops, Nasal Sprays & OTC Monograph Drugs (Industry Code 60–66 (Human OTC & Ophthalmic Drugs))](https://feilookup.com/category/ophthalmic-otc): 5-Yr Detention Rate: 27.1%, Avg Port Hold: 35 days. Top charges: INSANITARY_CONDITIONS, UNAPPROVED_NEW_DRUG, UNSAFE_COLOR.

## Statutory Charge Code & Form FDA 766 Relabeling Playbooks

- [FILTH (FD&C Act Section 402(a)(3)) — Adulterated: Consists in whole or in part of filthy, putrid, or decomposed substance](https://feilookup.com/violation/FILTH): FDA port inspectors or laboratory analysis detected insect fragments, rodent hair, mold, or decomposition in the shipment. Form FDA 766 Relabeling Eligible: No.
- [UNAPPROVED_NEW_DRUG (FD&C Act Section 505(a)) — Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims](https://feilookup.com/violation/UNAPPROVED_NEW_DRUG): The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA. Form FDA 766 Relabeling Eligible: Yes.
- [UNSAFE_COLOR (FD&C Act Section 601(e) / 402(c)) — Adulterated: Bears or contains an unsafe or uncertified color additive](https://feilookup.com/violation/UNSAFE_COLOR): The cosmetic or food item contains a dye/pigment either banned in the US or lacking an FDA batch certification number (e.g., FD&C Red No. 40 without batch cert). Form FDA 766 Relabeling Eligible: No.
- [NO_510K (FD&C Act Section 510(k)) — Adulterated / Misbranded Device: Lacks cleared Premarket Notification 510(k)](https://feilookup.com/violation/NO_510K): A Class I/II medical or aesthetic device was shipped to a US port without a valid FDA 510(k) clearance number or establishment registration. Form FDA 766 Relabeling Eligible: Yes.
- [NUTRITIONAL_LABELING (FD&C Act Section 403(q)) — Misbranded: Fails to bear required Nutrition Facts or Supplement Facts panel format](https://feilookup.com/violation/NUTRITIONAL_LABELING): The product label uses foreign nutrition tables (e.g., EU/CN per-100g format) instead of mandatory US FDA per-serving Nutrition/Supplement Facts formatting. Form FDA 766 Relabeling Eligible: Yes.
- [SALMONELLA (FD&C Act Section 402(a)(1)) — Adulterated: Appears to contain Salmonella, a poisonous and deleterious substance](https://feilookup.com/violation/SALMONELLA): FDA microbiological sampling or Import Alert 99-19 / 16-81 surveillance flagged the food, spice, or aquaculture shipment for Salmonella spp. contamination. Form FDA 766 Relabeling Eligible: No.
- [LISTERIA (FD&C Act Section 402(a)(1)) — Adulterated: Bears or contains Listeria monocytogenes](https://feilookup.com/violation/LISTERIA): Ready-to-eat (RTE) seafood, dairy, or botanical extract tested positive or is subject to DWPE for Listeria monocytogenes, a high-fatality foodborne pathogen. Form FDA 766 Relabeling Eligible: No.
- [INSANITARY_CONDITIONS (FD&C Act Section 402(a)(4) / 501(a)(2)(A)) — Adulterated: Prepared, packed, or held under insanitary conditions whereby it may have become contaminated](https://feilookup.com/violation/INSANITARY_CONDITIONS): An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage. Form FDA 766 Relabeling Eligible: No.