MESOSYSTEM S.A.
⚠️ High Risk
FEI: 3029621094 • Lisbon, Lisbon • PORTUGAL
FEI Number
3029621094
Location
Lisbon, Lisbon
Country
PORTUGALAddress
Avenida Da Republica 50 Piso 2, , Lisbon, Lisbon, Portugal
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
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 |
|---|---|---|---|
| 12/29/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/15/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/11/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/27/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/4/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MESOSYSTEM S.A.'s FDA import refusal history?
MESOSYSTEM S.A. (FEI: 3029621094) has 7 FDA import refusal record(s) in our database, spanning from 4/4/2025 to 12/29/2025.
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. MESOSYSTEM S.A.'s FEI number is 3029621094.
What types of violations has MESOSYSTEM S.A. received?
MESOSYSTEM S.A. has been cited for 1 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 MESOSYSTEM S.A. come from?
All FDA import refusal data for MESOSYSTEM 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.