Milan, Lombardy, Italy (IT)FEI: 3020192844DUNS: 431920811Dietary Supplements, Nutraceuticals & Botanicals

Milano Nutraceutica Liposomal S.r.l.

Raw CBP/OASIS Entity String: MILANO NUTRACEUTICA LIPOSOMAL S.R.L.

FSVP Lead Auditor Note: 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.

Primary US Port

Newark

Last FDA Inspection

2025-09-30

NAI (No Action Indicated)

Detained Cargo Value

$93,200

Across 2 holds

Est. US Containers/Yr

~175 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskMODERATE

24/ 100 Risk Score

5-Year Import Refusals:2

Active Warning Letters:0

FDA Enforcement Recalls:0

Yellow List — EU-to-US Nutrition Panel Surveillance

Shipment Held? Request 24h Legal Review

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

Source: CBP ACE Manifest + FDA OASIS Refusal Feed

May 2026

1 Held14 Cleared

Hold Rate: 7%

Jun 2026

0 Held16 Cleared

Hold Rate: 0%

Jul 2026

1 Held15 Cleared

Hold Rate: 6%

Aug 2026

1 Held13 Cleared

Hold Rate: 7%

Sep 2026

0 Held15 Cleared

Hold Rate: 0%

Oct 2026

0 Held16 Cleared

Hold Rate: 0%

Dataset 1 of 3 • FDA OASIS Import Refusals

Historical Port Detentions & Refusal Dispositions (2)

Entry # & Date	Port	Detained Product & FDA Code	Charge Code & Import Alert	Cargo Value	Final CBP/FDA Disposition
E12-4501922-0 2026-08-11	Newark	Liposomal Glutathione + Vitamin C Liquid Sachets (30x10mL) FDA Product Code: 54C	NUTRITIONAL_LABELING Import Alert 99-20	$54,000	Released After Form 766 Relabeling
E12-4291044-8 2025-11-28	Newark	Sublingual Vitamin D3 + K2 MK-7 Olive Oil Drops FDA Product Code: 54C	NUTRITIONAL_LABELING Import Alert 99-20	$39,200	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 #3020192844 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 #3020192844.

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Milano Nutraceutica Liposomal S.r.l.

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 →

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Full 5-year OASIS refusal history for Milano Nutraceutica Liposomal S.r.l. + 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 Milano Nutraceutica Liposomal S.r.l. 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.

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CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3020192844) 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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76/100

Milano Nutraceutica Liposomal S.r.l. Compliance FAQ

Is Milano Nutraceutica Liposomal S.r.l. (FEI 3020192844) on an FDA Import Alert Red List?

Milano Nutraceutica Liposomal S.r.l. currently carries a Composite FDA Risk Score of 24/100 (MODERATE) in DWPERadar records with status: Yellow List — EU-to-US Nutrition Panel Surveillance. Primary US port of entry is Newark. 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 Milano Nutraceutica Liposomal S.r.l.?

Across the 5-year OASIS refusal dataset, Milano Nutraceutica Liposomal S.r.l. has been cited for NUTRITIONAL_LABELING. Importers should review the statutory remediation checklists and Form FDA 766 eligibility before filing CBP entry.