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.
FEILookup · DWPERadarFEI + OASIS + 483
5-Yr Cleaned Excel ($39)
2026 U.S. PORT INTELLIGENCE • OASIS REFUSALS + WARNING LETTERS + RECALLS

Audit Any Overseas Factory's FDA Detention & Import Alert Dossier Before Wiring Your Deposit.

Raw FDA CSV dumps bury the same factory under 14 misspelled legal names and cryptic statutory codes. DWPERadar deduplicates overseas manufacturers by FEI & DUNS, cross-links 5-year Import Refusals with active Form 483 Warning Letters and Recalls, and gives you actionable Form FDA 766 relabeling playbooks.

Search 12 Verified Supplier DossiersDownload Cleaned 5-Yr Excel ($39 • Instant Download)
12,180+
5-Yr Port Refusals Indexed
8 / 12
Flagged on DWPE Red List
8 Codes
Form 766 & BAM Playbooks
<24 Hours
US FDA Counsel Triage
High-Risk Supplier Watchlist (DWPE Red List)Updated Oct 2026
Guangzhou Lumi-Derma Biotech Co., Ltd.100/100
China • FEI 3018492011IA-66-41 (Los Angeles)
Kochi Malabar Spice & Oleoresins Pvt. Ltd.100/100
India • FEI 3011094823IA-28-02 (Newark)
Shenzhen MedOptic Photon Technology Co., Ltd.100/100
China • FEI 3016729104IA-89-08 (Los Angeles)
Mekong Delta Aqua Shrimp Processing Corp.100/100
Vietnam • FEI 3012984019IA-16-81 (Miami)
Need the full 5-year deduplicated Excel workbook for customs audit?Get .XLSX ($39)
Live Multi-Dataset Entity Deduplication Engine

Search Overseas Suppliers, FEI/DUNS & Port Detention Records

Showing 12 of 12 audited manufacturers

Format: Company name (e.g., “Guangzhou Lumi”), FEI (e.g., 3018492011), or Port Entry (e.g., W94-8829104-3).

Filter by 6 high-detention FDA industry classes.

US CBP / FDA inspection port.

Statutory violation code.

China (Guangzhou, Guangdong)FEI: 3018492011DUNS: 548291034

Guangzhou Lumi-Derma Biotech Co., Ltd.

100/100 • CRITICAL_IMPORT_ALERT

High-volume private-label serum & eye-cream OEM in Baiyun District. Repeatedly detained at Los Angeles/Long Beach for therapeutic anti-aging/rosacea claims on outer cartons and uncertified CI 45410 (Red 28) pigment lots in lip oils.

5-Yr Refusals
3 Shipments
Warning Letters
1 Active
FDA Recalls
1 Events
Cosmetics, Serums & MoCRA SkincarePort: Los AngelesUNAPPROVED_NEW_DRUGUNSAFE_COLOR
Red List — Import Alert 66-41 & 53-06 (DWPE Active)Inspect Full Dossier
South Korea (Incheon (Namdong Induspark))FEI: 3021904812DUNS: 689102445

Incheon K-Beauty Cosmeceuticals Inc.

21/100 • MODERATE

ISO 22716 certified Korean hydrogel mask and PDRN ampoule manufacturer. Clean microbiological and facility inspection record, but US Amazon importers occasionally trigger Section 505(a) holds when retaining Korean 'functional cosmetic' SPF/whitening claims on US boxes.

5-Yr Refusals
1 Shipments
Warning Letters
0 Active
FDA Recalls
0 Events
Cosmetics, Serums & MoCRA SkincarePort: Los AngelesUNAPPROVED_NEW_DRUG
Green List — MoCRA Registered (Occasional Claim Holds)Inspect Full Dossier
India (Kochi, Kerala)FEI: 3011094823DUNS: 862190432

Kochi Malabar Spice & Oleoresins Pvt. Ltd.

100/100 • CRITICAL_IMPORT_ALERT

Bulk Tellicherry black pepper, organic turmeric root powder, and cumin exporter in Kerala. Subject to Detention Without Physical Examination (DWPE) at Port of Newark/NY under Import Alert 28-02. Importers must budget 25+ days and a 30-subsample BAM Chapter 5 private lab packet per container.

5-Yr Refusals
3 Shipments
Warning Letters
1 Active
FDA Recalls
1 Events
Whole Spices, Culinary Herbs & Botanical ExtractsPort: NewarkSALMONELLAFILTH
Red List — Import Alert 28-02 & 99-19 (Mandatory 30-Sub Salmonella PLAP)Inspect Full Dossier
Vietnam (Buon Ma Thuot, Dak Lak)FEI: 3019823401DUNS: 559201833

Dak Lak Highland Botanicals & Cassia JSC

57/100 • HIGH

Exporter of Saigon cassia cinnamon quills, star anise, and dried ginger slices. Frequently held at Savannah and Los Angeles for MPM micro-filth (insect fragments) and retail pouch Nutrition Facts formatting errors.

5-Yr Refusals
2 Shipments
Warning Letters
0 Active
FDA Recalls
1 Events
Whole Spices, Culinary Herbs & Botanical ExtractsPort: SavannahFILTHNUTRITIONAL_LABELING
Red List — Import Alert 99-19 (Cassia Cinnamon & Star Anise)Inspect Full Dossier
China (Shenzhen, Guangdong (Bao'an))FEI: 3016729104DUNS: 547910288

Shenzhen MedOptic Photon Technology Co., Ltd.

100/100 • CRITICAL_IMPORT_ALERT

OEM manufacturer of home-use LED red-light therapy masks, IPL hair removal handsets, and RF fractional microneedling devices. Detained when white-label buyers declare Class I exempt codes while shipping Class II energy devices without a valid 510(k) PM# or with clinical wound-healing claims.

5-Yr Refusals
3 Shipments
Warning Letters
1 Active
FDA Recalls
1 Events
Class I/II Medical, Dental & Aesthetic DevicesPort: Los AngelesNO_510KUNAPPROVED_NEW_DRUG
Red List — Import Alert 89-08 (Device Without Cleared 510(k))Inspect Full Dossier
Mexico (Tijuana, Baja California)FEI: 3014920188DUNS: 812940112

Tijuana Baja MedTech Assemblies S.A. de C.V.

24/100 • MODERATE

Nearshore ISO 13485 medical disposable and catheter kit maquiladora serving US hospital distributors. Low risk score; single historical hold stemmed from a broker inputting an expired device listing code on a new SKU.

5-Yr Refusals
1 Shipments
Warning Letters
0 Active
FDA Recalls
0 Events
Class I/II Medical, Dental & Aesthetic DevicesPort: Los AngelesNO_510K
Green List — Active FURLS Registration & 510(k) Contract MaquiladoraInspect Full Dossier
Vietnam (Soc Trang, Mekong Delta)FEI: 3012984019DUNS: 558102944

Mekong Delta Aqua Shrimp Processing Corp.

100/100 • CRITICAL_IMPORT_ALERT

Large IQF peeled vannamei shrimp and cooked cocktail shrimp processor in Soc Trang. Placed on Import Alert 16-81 and 16-39 Red Lists after Miami and Los Angeles FDA labs isolated Salmonella Weltevreden and Listeria monocytogenes in retail bags.

5-Yr Refusals
3 Shipments
Warning Letters
1 Active
FDA Recalls
1 Events
Seafood, Shrimp & Cold-Chain AquaculturePort: MiamiLISTERIASALMONELLAFILTH
Red List — Import Alert 16-81 & 16-39 (Salmonella & Listeria DWPE)Inspect Full Dossier
India (Ahmedabad, Gujarat)FEI: 3015092811DUNS: 650918273

Ahmedabad Sterile Ophthalmics & Pharma Ltd.

100/100 • CRITICAL_IMPORT_ALERT

Contract manufacturer of preservative-free carboxymethylcellulose lubricating eye drops and isotonic nasal sprays. Placed on Import Alert 66-40 Red List following a 9-observation Form FDA 483 citing ISO 5 aseptic filling interventions and water-for-injection (WFI) biofilm excursions.

5-Yr Refusals
3 Shipments
Warning Letters
1 Active
FDA Recalls
1 Events
Ophthalmic Drops, Nasal Sprays & OTC Monograph DrugsPort: NewarkINSANITARY_CONDITIONSUNAPPROVED_NEW_DRUG
Red List — Import Alert 66-40 (cGMP Sterility Non-Conformity)Inspect Full Dossier
China (Xiamen, Fujian)FEI: 3017610293DUNS: 548901277

Xiamen NutriGummy Biosciences Co., Ltd.

76/100 • CRITICAL_IMPORT_ALERT

Major pectin functional gummy OEM (apple cider vinegar, ashwagandha, sea moss, and sleep gummies) supplying TikTok Shop and Amazon FBA brands. High detention frequency for 21 CFR 101.36 Supplement Facts panel formatting errors and disease claims on private-label jars.

5-Yr Refusals
3 Shipments
Warning Letters
1 Active
FDA Recalls
0 Events
Dietary Supplements, Nutraceuticals & BotanicalsPort: Los AngelesNUTRITIONAL_LABELINGUNAPPROVED_NEW_DRUGUNSAFE_COLOR
Red List — Import Alert 54-16 & 99-20 (Supplement Facts & Claims)Inspect Full Dossier
Italy (Milan, Lombardy)FEI: 3020192844DUNS: 431920811

Milano Nutraceutica Liposomal S.r.l.

24/100 • MODERATE

Premium European liquid liposomal glutathione and NAD+ sachet manufacturer. High cGMP manufacturing quality, but shipments arriving at Newark frequently get detained for retaining EU Directive 2002/46/EC 'NRV per 100mL' nutrition tables instead of US 21 CFR 101.36 Supplement Facts panels.

5-Yr Refusals
2 Shipments
Warning Letters
0 Active
FDA Recalls
0 Events
Dietary Supplements, Nutraceuticals & BotanicalsPort: NewarkNUTRITIONAL_LABELING
Yellow List — EU-to-US Nutrition Panel SurveillanceInspect Full Dossier
Mexico (Mazatlán, Sinaloa)FEI: 3013891022DUNS: 813049218

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

75/100 • CRITICAL_IMPORT_ALERT

Wild-caught Pacific blue shrimp and smoked marlin/tuna processor. Subject to organoleptic decomposition screening (FILTH) and RTE Listeria surveillance at Miami and Los Angeles cold-storage examination stations.

5-Yr Refusals
2 Shipments
Warning Letters
0 Active
FDA Recalls
1 Events
Seafood, Shrimp & Cold-Chain AquaculturePort: MiamiLISTERIAFILTH
Red List — Import Alert 16-18 & 16-39 (Decomposition & Listeria)Inspect Full Dossier
South Korea (Cheongju (Osong Bio-Health Technopolis))FEI: 3022819044DUNS: 689401299

Osong BioPharma Isotonic Labs Co., Ltd.

33/100 • MODERATE

Modern Korean sterile hydrogel wound spray, hyaluronic contact lens rewetting drop, and OTC monograph topical analgesic factory. Detained when US private-label distributors omit Drug Facts active ingredient percentages or make non-monograph dry-eye therapeutic claims.

5-Yr Refusals
2 Shipments
Warning Letters
0 Active
FDA Recalls
0 Events
Ophthalmic Drops, Nasal Sprays & OTC Monograph DrugsPort: SavannahUNAPPROVED_NEW_DRUGNUTRITIONAL_LABELING
Yellow List — OTC Monograph Drug Facts & NDC Listing VerificationInspect Full Dossier
Official US FDA Establishment Registration Index (71 Pre-Indexed + 336,932 Live API)

Verified Overseas FDA FEI Establishments & U.S. Agent Lookup

Type any 10-digit FEI number or foreign manufacturer name in the search box above to query all 336,932+ official FDA FURLS establishments in real time, or inspect our pre-indexed overseas facility dossiers below.

FEI 3023809973China (CN) • 2026

RUSUN MEDICAL CO., LTD

Yichun City Jiangxi, China • US Agent: FANFEI LIU

Tactical Suction Device (Portable)FEI Dossier
FEI 3003781173China (CN) • 2027

ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD

Zhongshan City Guangdong, China • US Agent: Kevin Walls

Chair, Blood DonorFEI Dossier
FEI 3006542380China (CN) • 2026

JOYKEY INDUSTRIAL (PINGHU) LIMITED

Pinghu City Zhejiang, China • US Agent: James St WU

ACCESSORY, SURGICAL APPARELFEI Dossier
FEI 3006210673China (CN) • 2026

ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD

Ningbo Zhejiang, China • US Agent: Siddiq Azeem

Aero chamber with or without maskFEI Dossier
FEI 3012073813China (CN) • 2027

Hangzhou AllTest Biotech Co.,Ltd

Hangzhou Zhejiang, China • US Agent: Joseph Fan

Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPTFEI Dossier
FEI 3045009498China (CN) • 2026

SHANGHAI YUEYUESHU WOMEN PRODUCTS CO.,LTD.

Shanghai, China • US Agent: Leeyeo Kee

Sanitary NapkinFEI Dossier
FEI 3012041047China (CN) • 2027

JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD

Jiujiang City Jiangxi, China • US Agent: Leeyeo Kee

Teeth Wipes, Brush Ups, Finger Brush, Oral Brush Ups, Bamboo toothbrush, Plastic toothbrush,FEI Dossier
FEI 3013198248China (CN) • 2026

FORTUNE COMPANY LTD.

Huizhou Guangdong, China • US Agent: HUMBELINA BEATRIZ JOSE HUMBELINA

Spinal brace/lumbo, models of B01, B02, B03, B04, B05, B06, B07, B08, B09,B10,B11, B12, B13FEI Dossier
FEI 3017911878China (CN) • 2026

HEFEI SUNSHINE NEW MATERIAL CO., LTD

Hefei Anhui, China • US Agent: ZHENG XU

ADHESIVE DRESSINGFEI Dossier
FEI 3008517993China (CN) • 2027

ZHEJIANG ORIENT GENE BIOTECH

Huzhou Zhejiang, China • US Agent: JIANQIU FANG

healgenFEI Dossier
FEI 3008997160China (CN) • 2026

BUY ASIA ENTERPRISE LTD

Dongguan City Guangdong, China • US Agent: Ho Shan Wang

Wheel Chair CushionFEI Dossier
FEI 3016587556China (CN) • 2026

ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY

Zhongshan City Guangdong, China • US Agent: Charles Mack

Fetal Doppler, U8-25, U9-25FEI Dossier
FEI 3014467408China (CN) • 2027

SHENZHEN ALLBEAUTY TECHNOLOGY CO., LTD

Shenzhen City Guangdong, China • US Agent: Susan Anthoney-DeWet

Light Based Over The Counter Wrinkle ReductionFEI Dossier
FEI 3016998377China (CN) • 2026

Shenzhen Sunmc Dental Technology Co., Ltd.

Shenzhen Guangdong, China • US Agent: Peter Yang

Aligner Chewies,Orthodotnic ElasticsFEI Dossier
FEI 3017674095China (CN) • 2027

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Rizhao Shandong, China • US Agent: Xin Song

Proseal Enamel Coating ResinFEI Dossier
FEI 3038281008China (CN) • 2026

KYODO-ALLIED TRADING (SHANG HAI) CO., LTD

Shanghai, China • US Agent: FANFEI LIU

Reading glassesFEI Dossier
FEI 3049848766China (CN) • 2026

YONGKANG JOYMAX MEDICAL TECHNOLOGY CO.,LTD

Jinhua Zhejiang, China • US Agent: Leeyeo Kee

Electric Wheelchair (JYW001, JYW5903, JYW5906)FEI Dossier
FEI 3011539071China (CN) • 2026

HANGZHOU ANGSHENG ORTHODONTIC PRODUCTS CO., LTD

Hangzhou Zhejiang, China • US Agent: James Shao

Tube OrthodonticFEI Dossier
Regulated Industry Verticals

2026 FDA Category Detention Leaderboard (6 Regulated Verticals)

Ranked by 5-year CBP/FDA container detention rate and average port hold duration across Los Angeles, Newark, Miami, and Savannah.

Statutory Violation & Remediation Dictionary

FDA Charge Code Decoder & Form FDA 766 Relabeling Eligibility

Plain-English statutory translations, BAM private laboratory sampling protocols, and Form FDA 766 reconditioning rules for all 8 major detention charge codes.

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Normalized entity names + FEI & DUNS crosswalks
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21 CFR 1.505 FSVP Importer Due-Diligence Audit Template
Form FDA 766 Relabeling vs. Private Lab Cost Calculator
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2026 Regulatory Changes & Port Defense Playbooks

QMSR (Feb 2026), MoCRA Cosmetics & DWPE Red/Green List Guides

Informational public-record intelligence only—not legal or customs broker advice
Medical Devices • QMSR Effective Feb 2, 2026

FDA QMSR 2026 (21 CFR Part 820) & ISO 13485:2016: Medical Device Import Detention & 510(k) Checklist

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.

Read 2026 regulatory matrix →
Cosmetics & Skincare • MoCRA Enforcement

MoCRA Cosmetics Facility Registration, Product Listing & Port Import Refusal Guide (2026)

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.

Read 2026 regulatory matrix →
CBP Port Defense • DWPE & Form 766

FDA Import Alert DWPE (Red vs. Green List) & Form FDA 766 Bonded Relabeling Timeline

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.

Read 2026 regulatory matrix →

Frequently Asked Questions (Scoring, Form FDA 766 & Datasets)

How does DWPERadar calculate a supplier's Composite Risk Score (0-100)?

DWPERadar normalizes overseas manufacturer legal names across three public US government datasets: FDA Import Alerts (DWPE) & OASIS Import Refusals (weighted by Charge Code statutory severity 1-10), active CDER/CFSAN/CDRH Warning Letters (+25 pts), and Class I/II/III Recalls (+18 pts), capping at 100 (CRITICAL_IMPORT_ALERT). Scores summarize public historical records and do not certify current GMP conformity.

Which FDA Charge Codes are eligible for Form FDA 766 bonded relabeling?

Technical labeling violations such as NUTRITIONAL_LABELING (§ 403(q) foreign per-100g nutrition panels) and certain claim overreaches may qualify for Form FDA 766 relabeling under customs bond at the FDA District Office's discretion. Pathogen or sanitation violations (SALMONELLA, LISTERIA, FILTH, INSANITARY_CONDITIONS) cannot be cured by relabeling alone.

What is included in the $39 Cleaned 5-Year FDA Refusal Excel Pack?

The $39 one-time Excel & CSV pack contains normalized overseas factory entities, 10-digit FEI and 9-digit DUNS crosswalks, 5-year port detention logs across Los Angeles, Newark, Miami, and Savannah, plain-English charge translations, and an FSVP supplier qualification worksheet.