Wellable Group Marine Biological & Chemical Co., LTD
⚠️ High Risk
FEI: 3004294242 • Shishi, Fujian • CHINA
FEI Number
3004294242
Location
Shishi, Fujian
Country
CHINAAddress
Dabao Development Zone, , Shishi, Fujian, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
807REFUSAL
The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2015 | 55PY01GLUCOSAMINE (PHARMACEUTIC NECESSITY) | New Orleans District Office (NOL-DO) | |
| 9/18/2014 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/26/2014 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3846807REFUSAL | Los Angeles District Office (LOS-DO) |
| 6/26/2014 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3846807REFUSAL | Los Angeles District Office (LOS-DO) |
| 6/26/2014 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3846807REFUSAL | Los Angeles District Office (LOS-DO) |
| 6/26/2014 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3846807REFUSAL | Los Angeles District Office (LOS-DO) |
| 6/10/2014 | 41YGT99DIETARY CONVENTIONAL FOODS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/10/2014 | 41YGT99DIETARY CONVENTIONAL FOODS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/28/2014 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3846807REFUSAL | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Wellable Group Marine Biological & Chemical Co., LTD's FDA import refusal history?
Wellable Group Marine Biological & Chemical Co., LTD (FEI: 3004294242) has 9 FDA import refusal record(s) in our database, spanning from 5/28/2014 to 3/16/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Wellable Group Marine Biological & Chemical Co., LTD's FEI number is 3004294242.
What types of violations has Wellable Group Marine Biological & Chemical Co., LTD received?
Wellable Group Marine Biological & Chemical Co., LTD has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Wellable Group Marine Biological & Chemical Co., LTD come from?
All FDA import refusal data for Wellable Group Marine Biological & Chemical Co., LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.