Guangzhou, Guangdong, China (CN)FEI: 3018492011DUNS: 548291034Cosmetics, Serums & MoCRA Skincare

Guangzhou Lumi-Derma Biotech Co., Ltd.

Raw CBP/OASIS Entity String: GUANGZHOU LUMI-DERMA BIOTECH CO., LTD.

FSVP Lead Auditor Note: 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.

Primary US Port

Los Angeles

Last FDA Inspection

2026-04-18

OAI (Official Action Indicated)

Detained Cargo Value

$154,100

Across 3 holds

Est. US Containers/Yr

~145 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskCRITICAL_IMPORT_ALERT

100/ 100 Risk Score

5-Year Import Refusals:3

Active Warning Letters:1

FDA Enforcement Recalls:1

Red List — Import Alert 66-41 & 53-06 (DWPE Active)

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

4 Held9 Cleared

Hold Rate: 31%

Jun 2026

5 Held8 Cleared

Hold Rate: 38%

Jul 2026

3 Held10 Cleared

Hold Rate: 23%

Aug 2026

4 Held7 Cleared

Hold Rate: 36%

Sep 2026

6 Held6 Cleared

Hold Rate: 50%

Oct 2026

5 Held7 Cleared

Hold Rate: 42%

Dataset 1 of 3 • FDA OASIS Import Refusals

Historical Port Detentions & Refusal Dispositions (3)

Entry # & Date	Port	Detained Product & FDA Code	Charge Code & Import Alert	Cargo Value	Final CBP/FDA Disposition
W94-8829104-3 2026-09-14	Los Angeles	Exosome Peptide Barrier Repair Serum (30mL Retail Cartons) FDA Product Code: 53I	UNAPPROVED_NEW_DRUG Import Alert 66-41	$64,200	Released After Form 766 Relabeling
W94-8710293-1 2026-06-22	Los Angeles	Velvet Glow Tinted Lip & Eye Stain (Uncertified Red Lake) FDA Product Code: 53D	UNSAFE_COLOR Import Alert 53-06	$38,900	Refused & Exported
W94-8401922-8 2025-11-09	Newark	Tranexamic Acid Melasma Clinical Ampoule FDA Product Code: 53I	UNAPPROVED_NEW_DRUG Import Alert 66-41	$51,000	Refused & Exported

Dataset 2 of 3 • CDER / CFSAN / CDRH Enforcement

FDA Warning Letters & Form 483 Citations (1)

CMS-679412 • Issued 2026-05-12Active / Open

CDER Office of Unapproved Drugs and Labeling Compliance

Unapproved New Drugs Marketed as OTC/Cosmetic Exosome & Microneedling Serums

FDA reviewed B2B catalog and private-label packaging inserts claiming products 'regenerate damaged dermal tissue and cure chronic rosacea'. Placed on Import Alert 66-41 Red List.

FD&C Act § 505(a)FD&C Act § 502(f)(1)21 CFR § 701.3

Dataset 3 of 3 • RES Recall Enterprise System

5-Year US Market Recalls (1)

Recall #F-0412-2026 (2026-02-19)Class II

Botanical Brightening Eye Gel (15mL Airless Pump)

Reason: Contains D&C Red No. 27 lake not certified by FDA batch testing and prohibited for eye-area use.

Distribution Scope: 18,400 units nationwide

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Guangzhou Lumi-Derma Biotech Co., Ltd.

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 →

UNSAFE_COLOR (FD&C Act Section 601(e) / 402(c))Form 766 Ineligible (Lab/Export)

Adulterated: Bears or contains an unsafe or uncertified color additive

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).

Importer Remediation Checklist:

Request FDA Color Additive Lot Certification numbers from the raw pigment supplier.
Cross-check eye-area cosmetics against 21 CFR Part 73/74 restricted color lists.

Typical Hold: 15–25 calendar daysView Full UNSAFE_COLOR Form 766 Playbook →

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Full 5-year OASIS refusal history for Guangzhou Lumi-Derma Biotech Co., Ltd. + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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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 Guangzhou Lumi-Derma Biotech Co., Ltd. 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.

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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., 3018492011) 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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21/100

Guangzhou Lumi-Derma Biotech Co., Ltd. Compliance FAQ

Is Guangzhou Lumi-Derma Biotech Co., Ltd. (FEI 3018492011) on an FDA Import Alert Red List?

Guangzhou Lumi-Derma Biotech Co., Ltd. currently carries a Composite FDA Risk Score of 100/100 (CRITICAL_IMPORT_ALERT) in DWPERadar records with status: Red List — Import Alert 66-41 & 53-06 (DWPE Active). 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 Guangzhou Lumi-Derma Biotech Co., Ltd.?

Across the 5-year OASIS refusal dataset, Guangzhou Lumi-Derma Biotech Co., Ltd. has been cited for UNAPPROVED_NEW_DRUG, UNSAFE_COLOR. Importers should review the statutory remediation checklists and Form FDA 766 eligibility before filing CBP entry.