Incheon (Namdong Induspark), South Korea (KR)FEI: 3021904812DUNS: 689102445Cosmetics, Serums & MoCRA Skincare

Incheon K-Beauty Cosmeceuticals Inc.

Raw CBP/OASIS Entity String: INCHEON K-BEAUTY COSMECEUTICALS INC.

FSVP Lead Auditor Note: 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.

Primary US Port

Los Angeles

Last FDA Inspection

2025-10-04

NAI (No Action Indicated)

Detained Cargo Value

$42,800

Across 1 holds

Est. US Containers/Yr

~310 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskMODERATE

21/ 100 Risk Score

5-Year Import Refusals:1

Active Warning Letters:0

FDA Enforcement Recalls:0

Green List — MoCRA Registered (Occasional Claim Holds)

Shipment Held? Request 24h Legal Review

6-Month Port Detention vs. Cleared Entry Velocity (Los Angeles)

Source: CBP ACE Manifest + FDA OASIS Refusal Feed

May 2026

0 Held26 Cleared

Hold Rate: 0%

Jun 2026

1 Held25 Cleared

Hold Rate: 4%

Jul 2026

1 Held28 Cleared

Hold Rate: 3%

Aug 2026

0 Held29 Cleared

Hold Rate: 0%

Sep 2026

0 Held27 Cleared

Hold Rate: 0%

Oct 2026

1 Held26 Cleared

Hold Rate: 4%

Dataset 1 of 3 • FDA OASIS Import Refusals

Historical Port Detentions & Refusal Dispositions (1)

Entry # & Date	Port	Detained Product & FDA Code	Charge Code & Import Alert	Cargo Value	Final CBP/FDA Disposition
W94-9012441-0 2026-07-29	Los Angeles	Centella SPF50+ PA++++ Tone-Up Sun Essence (Unlisted UV Filter) FDA Product Code: 53I	UNAPPROVED_NEW_DRUG Import Alert 66-41	$42,800	Released After Form 766 Relabeling

Dataset 2 of 3 • CDER / CFSAN / CDRH Enforcement

FDA Warning Letters & Form 483 Citations (0)

No active FDA Warning Letters recorded for FEI #3021904812 in the last 5 years.

Dataset 3 of 3 • RES Recall Enterprise System

5-Year US Market Recalls (0)

Zero Class I, II, or III FDA product recalls linked to FEI #3021904812.

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Incheon K-Beauty Cosmeceuticals Inc.

UNAPPROVED_NEW_DRUG (FD&C Act Section 505(a))Form FDA 766 Relabeling Eligible

Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims

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.

Importer Remediation Checklist:

Audit all product box copy, package inserts, and linked Shopify/Amazon URLs for therapeutic verbs ('cures', 'treats inflammation', 'heals acne').
File an FDA Relabeling Application (Form FDA 766) if the violation is purely on physical packaging.
Verify active ingredients against OTC Monograph compliance requirements.

Typical Hold: 14–28 calendar daysView Full UNAPPROVED_NEW_DRUG Form 766 Playbook →

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Includes all deduplicated overseas factory names, FEI/DUNS crosswalks, 5-year port refusal logs, plain-English statutory violation mappings, and FSVP supplier qualification templates ready for customs broker review.

Full 5-year OASIS refusal history for Incheon K-Beauty Cosmeceuticals Inc. + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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FEI #3021904812 Watchdog$15 / month

Instant Supplier Detention Webhook & Email Alert Monitor

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 Incheon K-Beauty Cosmeceuticals Inc. 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)

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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., 3021904812) 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.

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100/100

Incheon K-Beauty Cosmeceuticals Inc. Compliance FAQ

Is Incheon K-Beauty Cosmeceuticals Inc. (FEI 3021904812) on an FDA Import Alert Red List?

Incheon K-Beauty Cosmeceuticals Inc. currently carries a Composite FDA Risk Score of 21/100 (MODERATE) in DWPERadar records with status: Green List — MoCRA Registered (Occasional Claim Holds). Primary US port of entry is Los Angeles. Historical records are informational only and should be cross-checked on official FDA dashboards before CBP filing.

What are the main FDA Charge Codes cited against Incheon K-Beauty Cosmeceuticals Inc.?

Across the 5-year OASIS refusal dataset, Incheon K-Beauty Cosmeceuticals Inc. has been cited for UNAPPROVED_NEW_DRUG. Importers should review the statutory remediation checklists and Form FDA 766 eligibility before filing CBP entry.