Gaes S.A.
⚠️ Moderate Risk
FEI: 3001078648 • Barcelona, Barcelona • SPAIN
FEI Number
3001078648
Location
Barcelona, Barcelona
Country
SPAINAddress
Placa De Pedro 160, , Barcelona, Barcelona, Spain
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2015 | 77EWCCHAMBER, ACOUSTIC (FOR AUDIOMETRIC TESTING) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2015 | 77EQNLARYNGOSCOPE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2015 | 77ERAOTOSCOPE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2015 | 77NASTYMPANOMETER | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2015 | 77EWOAUDIOMETER | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2015 | 77EWOAUDIOMETER | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Gaes S.A.'s FDA import refusal history?
Gaes S.A. (FEI: 3001078648) has 6 FDA import refusal record(s) in our database, spanning from 8/13/2015 to 8/13/2015.
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. Gaes S.A.'s FEI number is 3001078648.
What types of violations has Gaes S.A. received?
Gaes 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 Gaes S.A. come from?
All FDA import refusal data for Gaes 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.