Research Desk Online

EASTCAP TRADE INTELLIGENCE

Automated Regulatory Screening & Pre-Procurement Port-Risk Analytics

Port Refusal History

Cross-references historical FDA OASIS action logs and detention codes before issuing supplier purchase orders.

Import Alert Status

Verifies active Detention Without Physical Examination (DWPE) Red Lists by foreign manufacturer identifier (FEI).

Section 801(a) Analysis

Surfaces recurrent statutory admissibility charges, registration lapses, and unverified device clearances.

Operational Risk: The Cost of Inactive Supplier Compliance

Unregistered Foreign Facilities (§ 510) A foreign supplier failing to renew their active FDA registration results in automatic shipment holds at arrival. Goods cannot be cleared, leading to carrier container demurrage and pier detention fees ($250–$600+/day).
Unlisted Import Alerts (DWPE) Sourcing from an entity on an active Import Alert Red List triggers immediate Detention Without Physical Examination. Overcoming DWPE requires third-party certified laboratory testing or formal petitioning at the importer's expense.
Refusal & Liquidated Damages (§ 1484) If admissibility charges are not resolved within 90 days, CBP issues a mandatory Notice of Redelivery for export or supervised destruction. Failure to return goods triggers CBP liquidated damages of up to 3x total shipment value.

Analytical Output Formats (Redacted Public Data)

Sample 1 of 3
live_intel_feed.log
• Rotating Case Studies
=================================================================================================== EASTCAP REGULATORY RISK DOSSIER — CASE PROFILE A (PHARMACEUTICAL / DEVICES) Database: OASIS / FDA Public Index | Scope: Historical Admissibility Records =================================================================================================== RECORD SEARCH CRITERIA: • Declared Entity : Janytree Incorporated (Public Registry Record) • FEI Identifier : 3012662975 • Declared Origin : 67 Gasandijiteol2-Ro, Geumcheon, Seoul, South Korea --------------------------------------------------------------------------------------------------- SCREENING RESULT: [ELEVATED RISK] HISTORICAL ADMISSIBILITY DEFICIENCIES NOTED • Active DWPE Red List Status : Negative in Query Index • Historical Port Refusals (Public) : 8 Verified Records Located --------------------------------------------------------------------------------------------------- HISTORICAL RECORD RECAP: • 2026-09-10 | Port: DSEI | Item: [66YDP99] Other Drug Related Items - Sec. 510: Facility Unregistered on Transaction Date - Sec. 505(a): Lack of Validated New Drug Application • 2026-09-03 | Port: DSEI | Item: [66VIK99] Miscellaneous Patent Medicines - Sec. 510: Product Listing Deficient • 2026-08-14 | Port: DSEI | Item: [79LMH] Dermal Aesthetic Implants - Sec. 501(f)(1)(B): Adulterated Device (Premarket 510(k) Unverified) OBSERVATIONAL COMPLIANCE NOTES: • Verification Step: Verify current active FEI status and validated 510(k) documentation directly. =================================================================================================== LEGAL NOTICE: Public research compilation only. Not legal advice or customs brokerage (19 U.S.C. § 1641). Importer retains exclusive reasonable care obligations (19 U.S.C. § 1484). Subject to /terms.html. ===================================================================================================
=================================================================================================== EASTCAP REGULATORY RISK DOSSIER — CASE PROFILE B (ELECTRO-MEDICAL HARDWARE) Database: OASIS / CDRH Index | Scope: Historical Admissibility Records =================================================================================================== RECORD SEARCH CRITERIA: • Declared Entity : Shenzhen Biolight Electronics (Public Registry Record) • FEI Identifier : 3004819201 • Declared Origin : Nanshan High-Tech Park, Shenzhen, Guangdong, China --------------------------------------------------------------------------------------------------- SCREENING RESULT: [CRITICAL RISK] ACTIVE DWPE IMPORT ALERT & CHARGES LOGGED • Active DWPE Red List Status : AFFIRMATIVE — Import Alert 89-08 (Detention Without Exam) • Historical Port Refusals (Public) : 14 Verified Records Located --------------------------------------------------------------------------------------------------- HISTORICAL RECORD RECAP: • 2026-05-18 | Port: LAX | Item: [74JCT] Patient Monitoring Accessories - Sec. 501(h): Failure to Conform to Current Good Manufacturing Practices (CGMP / QSR) • 2026-03-22 | Port: LGB | Item: [74DXN] Diagnostic Electrodes - Sec. 502(o): Failure to Submit Device Listing Information Under Section 510(j) • 2025-11-09 | Port: SEA | Item: [74KRD] Clinical Pulse Oximeter Systems - Sec. 801(a)(3): Appears Adulterated under Medical Device Quality System Regulations OBSERVATIONAL COMPLIANCE NOTES: • Verification Step: Subject to Import Alert 89-08; require audited third-party laboratory evidence. =================================================================================================== LEGAL NOTICE: Public research compilation only. Not legal advice or customs brokerage (19 U.S.C. § 1641). Importer retains exclusive reasonable care obligations (19 U.S.C. § 1484). Subject to /terms.html. ===================================================================================================
=================================================================================================== EASTCAP REGULATORY RISK DOSSIER — CASE PROFILE C (BOTANICAL & DIETARY INGREDIENTS) Database: OASIS / CFSAN Index | Scope: Historical Admissibility Records =================================================================================================== RECORD SEARCH CRITERIA: • Declared Entity : Vinh Wellness Extracts Ltd (Public Registry Record) • FEI Identifier : 3009182374 • Declared Origin : Song Than Industrial Zone, Binh Duong, Vietnam --------------------------------------------------------------------------------------------------- SCREENING RESULT: [ELEVATED RISK] REPEAT 801(a) ADULTERATION REFUSALS • Active DWPE Red List Status : Negative in Query Index • Historical Port Refusals (Public) : 5 Verified Records Located --------------------------------------------------------------------------------------------------- HISTORICAL RECORD RECAP: • 2026-07-02 | Port: OAK | Item: [54EGD99] Dietary Botanical Powders - Sec. 402(a)(2)(C)(i): Contains Unapproved Food Additive / Pesticide Residue • 2026-02-14 | Port: HOU | Item: [54FBM01] Marine Collagen Hydrolysate - Sec. 403(a)(1): Misbranded; Labeling False and Misleading Regarding Identity • 2025-10-19 | Port: MIA | Item: [54EAA02] Concentrated Herbal Extracts - Sec. 801(a)(1): Appears to Have Been Prepared, Packed, or Held Under Insanitary Conditions OBSERVATIONAL COMPLIANCE NOTES: • Verification Step: Demand full Certificate of Analysis (CoA) and independent foreign lab verification. =================================================================================================== LEGAL NOTICE: Public research compilation only. Not legal advice or customs brokerage (19 U.S.C. § 1641). Importer retains exclusive reasonable care obligations (19 U.S.C. § 1484). Subject to /terms.html. ===================================================================================================

Closed Beta Evaluation for Trade Professionals

Request an automated regulatory data screening compilation for prospective contract suppliers or pending consignments.

Request Data Screening
By clicking "Request Data Screening" or using an Eastcap dossier, you affirm that you have read and agree to our Terms of Service and acknowledge your independent duties under 19 U.S.C. § 1484.