Cheongju (Osong Bio-Health Technopolis), South Korea (KR)FEI: 3022819044DUNS: 689401299Ophthalmic Drops, Nasal Sprays & OTC Monograph Drugs

Osong BioPharma Isotonic Labs Co., Ltd.

Raw CBP/OASIS Entity String: OSONG BIOPHARMA ISOTONIC LABS CO., LTD.

FSVP Lead Auditor Note: 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.

Primary US Port

Savannah

Last FDA Inspection

2026-02-09

VAI (Voluntary Action Indicated)

Detained Cargo Value

$134,500

Across 2 holds

Est. US Containers/Yr

~150 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskMODERATE

33/ 100 Risk Score

5-Year Import Refusals:2

Active Warning Letters:0

FDA Enforcement Recalls:0

Yellow List — OTC Monograph Drug Facts & NDC Listing Verification

Shipment Held? Request 24h Legal Review

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

Source: CBP ACE Manifest + FDA OASIS Refusal Feed

May 2026

1 Held12 Cleared

Hold Rate: 8%

Jun 2026

1 Held11 Cleared

Hold Rate: 8%

Jul 2026

2 Held10 Cleared

Hold Rate: 17%

Aug 2026

1 Held12 Cleared

Hold Rate: 8%

Sep 2026

2 Held11 Cleared

Hold Rate: 15%

Oct 2026

1 Held13 Cleared

Hold Rate: 7%

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
S41-2301944-0 2026-09-02	Savannah	Sodium Hyaluronate 0.3% Multi-Dose Ophthalmic Comfort Drops FDA Product Code: 66V	UNAPPROVED_NEW_DRUG Import Alert 66-41	$88,000	Refused & Exported
W94-8691022-3 2026-03-19	Los Angeles	Menthol + Camphor Cooling Hydrogel Pain Relief Patch (Missing Drug Facts Box) FDA Product Code: 60H	NUTRITIONAL_LABELING Import Alert 66-41	$46,500	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 #3022819044 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 #3022819044.

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Osong BioPharma Isotonic Labs 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 →

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 Osong BioPharma Isotonic Labs 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 Osong BioPharma Isotonic Labs 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.

Your Full Name & Role (Required)

Include your name and title (e.g., “Sarah Chen, VP Supply Chain”).

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., 3022819044) 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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Ahmedabad Sterile Ophthalmics & Pharma Ltd.

India • FEI 3015092811 • Red List — Import Alert 66-40 (cGMP Sterility Non-Conformity)

100/100

Osong BioPharma Isotonic Labs Co., Ltd. Compliance FAQ

Is Osong BioPharma Isotonic Labs Co., Ltd. (FEI 3022819044) on an FDA Import Alert Red List?

Osong BioPharma Isotonic Labs Co., Ltd. currently carries a Composite FDA Risk Score of 33/100 (MODERATE) in DWPERadar records with status: Yellow List — OTC Monograph Drug Facts & NDC Listing Verification. Primary US port of entry is Savannah. 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 Osong BioPharma Isotonic Labs Co., Ltd.?

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