LABORATOIRES FILL-MED MANUFACTURING S.A.
⚠️ High Risk
FEI: 3038109130 • Anderlecht • BELGIUM
FEI Number
3038109130
Location
Anderlecht
Country
BELGIUMAddress
Boulevard Paepsem 8, , Anderlecht, , Belgium
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 11/26/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/26/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/26/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATOIRES FILL-MED MANUFACTURING S.A.'s FDA import refusal history?
LABORATOIRES FILL-MED MANUFACTURING S.A. (FEI: 3038109130) has 3 FDA import refusal record(s) in our database, spanning from 11/26/2025 to 11/26/2025.
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. LABORATOIRES FILL-MED MANUFACTURING S.A.'s FEI number is 3038109130.
What types of violations has LABORATOIRES FILL-MED MANUFACTURING S.A. received?
LABORATOIRES FILL-MED MANUFACTURING S.A. has been cited for 2 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 LABORATOIRES FILL-MED MANUFACTURING S.A. come from?
All FDA import refusal data for LABORATOIRES FILL-MED MANUFACTURING S.A. 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.