Xiamen, Fujian, China (CN)FEI: 3017610293DUNS: 548901277Dietary Supplements, Nutraceuticals & Botanicals

Xiamen NutriGummy Biosciences Co., Ltd.

Raw CBP/OASIS Entity String: XIAMEN NUTRIGUMMY BIOSCIENCES CO., LTD.

FSVP Lead Auditor Note: 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.

Primary US Port

Los Angeles

Last FDA Inspection

2026-01-14

VAI (Voluntary Action Indicated)

Detained Cargo Value

$153,600

Across 3 holds

Est. US Containers/Yr

~280 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskCRITICAL_IMPORT_ALERT

76/ 100 Risk Score

5-Year Import Refusals:3

Active Warning Letters:1

FDA Enforcement Recalls:0

Red List — Import Alert 54-16 & 99-20 (Supplement Facts & Claims)

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 Held19 Cleared

Hold Rate: 17%

Jun 2026

3 Held21 Cleared

Hold Rate: 13%

Jul 2026

5 Held18 Cleared

Hold Rate: 22%

Aug 2026

4 Held20 Cleared

Hold Rate: 17%

Sep 2026

5 Held17 Cleared

Hold Rate: 23%

Oct 2026

3 Held22 Cleared

Hold Rate: 12%

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
W94-9102938-2 2026-09-25	Los Angeles	Sea Moss + Burdock + Bladderwrack Pectin Gummies (60ct Bottles) FDA Product Code: 54Y	NUTRITIONAL_LABELING Import Alert 99-20	$48,200	Released After Form 766 Relabeling
W94-8891023-9 2026-07-04	Los Angeles	Berberine + Ceylon Cinnamon Blood Sugar Control Gummies FDA Product Code: 54E	UNAPPROVED_NEW_DRUG Import Alert 54-16	$71,500	Refused & Exported
S41-2091844-6 2026-03-12	Savannah	Kids Elderberry Immune Chewable Drops (Red Dye Uncertified) FDA Product Code: 54C	UNSAFE_COLOR Import Alert 45-02	$33,900	Released After Form 766 Relabeling

Dataset 2 of 3 • CDER / CFSAN / CDRH Enforcement

FDA Warning Letters & Form 483 Citations (1)

CMS-671029 • Issued 2026-02-28Active / Open

CFSAN Office of Dietary Supplement Programs (ODSP)

Dietary Supplement CGMP (21 CFR Part 111) & Misbranding Violations

Failed to conduct at least one identity test on incoming botanical ashwagandha root extract before compounding, and declared dietary ingredients inside the 2% Daily Value box in incorrect order.

21 CFR § 111.75(a)(1)(i)21 CFR § 101.36FD&C Act § 403(q)(5)(F)

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 #3017610293.

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Xiamen NutriGummy Biosciences Co., Ltd.

NUTRITIONAL_LABELING (FD&C Act Section 403(q))Form FDA 766 Relabeling Eligible

Misbranded: Fails to bear required Nutrition Facts or Supplement Facts panel format

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.

Importer Remediation Checklist:

Submit Form FDA 766 proposing custom sticker relabeling under bond before customs liquidation.
Update dielines to 21 CFR 101.9 (Nutrition Facts) font size and declaration standards.

Typical Hold: 10–18 calendar daysView Full NUTRITIONAL_LABELING Form 766 Playbook →

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 →

TIER 2 • PROCUREMENT DATA & REAL-TIME OASIS WEBHOOK MONITORFEI #3017610293 • Instant Delivery

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

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FEI #3017610293 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 Xiamen NutriGummy Biosciences 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., 3017610293) 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.

Compare Alternative Suppliers in Dietary Supplements, Nutraceuticals & Botanicals

View Category Detention Report →

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Italy • FEI 3020192844 • Yellow List — EU-to-US Nutrition Panel Surveillance

24/100

Xiamen NutriGummy Biosciences Co., Ltd. Compliance FAQ

Is Xiamen NutriGummy Biosciences Co., Ltd. (FEI 3017610293) on an FDA Import Alert Red List?

Xiamen NutriGummy Biosciences Co., Ltd. currently carries a Composite FDA Risk Score of 76/100 (CRITICAL_IMPORT_ALERT) in DWPERadar records with status: Red List — Import Alert 54-16 & 99-20 (Supplement Facts & Claims). 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 Xiamen NutriGummy Biosciences Co., Ltd.?

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