JINGXIN GROUP (M) SDN BHD
Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for JINGXIN GROUP (M) SDN BHD (FEI 3033511100). Use this record to cross-check CBP ACE Affirmation of Compliance codes (`DEV` / `DFE` / `FEI`), verify the designated US Agent on file, and subscribe to automated Import Alert (DWPE) monitoring.
No.60, Jalan i-Park 1/5, Kawasan Perindustrian i-Park, Bandar Indahpura
Kulai Johor, Malaysia (81000)
FEI Number: 3033511100
Registration No: 3033511100 • Status Code: 1 (Active)
Creekon Yang
SPICA MEDTECH CORP
Denver, CO (USA)
720-6176666
fda.agent@spicagloble.com
Registered FDA Product Codes, Device Classes & Commercial Names
Cross-check your commercial invoice product descriptions against these active FDA product code filings to prevent NO_510K or UNAPPROVED_NEW_DRUG port holds.
Proprietary / Commercial Brand Names on File
| Product Code | FDA Classification Name | Device Class | 21 CFR Regulation | 510(k) Exempt? |
|---|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | Class 1 | 21 CFR 884.5435 | Requires 510(k) / Check |
Download Normalized 5-Year Refusal, 483 & Recall Audit Workbook (.XLSX + CSV)
Includes all deduplicated overseas factory names, FEI/DUNS crosswalks, 5-year port refusal logs, plain-English statutory violation mappings, and FSVP supplier qualification templates ready for customs broker review.
- Full 5-year OASIS refusal history for JINGXIN GROUP (M) SDN BHD (FEI 3033511100) + category peers
- 21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab
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 JINGXIN GROUP (M) SDN BHD (FEI 3033511100) before you wire your 70% balance payment.
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.
Other Verified FDA FEI Establishments in Malaysia
Frequently Asked Questions: FEI 3033511100 (JINGXIN GROUP (M) SDN BHD)
What is the FDA FEI Number for JINGXIN GROUP (M) SDN BHD?
According to public US FDA Establishment Registration records, JINGXIN GROUP (M) SDN BHD (Kulai Johor, Malaysia) is assigned FDA Facility Establishment Identifier (FEI) 3033511100 (Registration No. 3033511100) with registration year 2026.
Who is the designated US Agent for FEI 3033511100 (JINGXIN GROUP (M) SDN BHD)?
The registered US Agent on file for FEI 3033511100 is Creekon Yang (SPICA MEDTECH CORP) located in Denver, CO. Importers should independently confirm active representation before filing CBP ACE entry.
Does an active FDA FEI registration guarantee that shipments from JINGXIN GROUP (M) SDN BHD will clear US Customs without detention?
No. An active FDA FEI number or establishment registration only confirms administrative listing in FDA FURLS. Shipments can still be detained at US ports under Detention Without Physical Examination (DWPE / Import Alerts) for labeling, 510(k), cGMP, or adulteration violations.