Microtek Medical Malta Limited
⚠️ Moderate Risk
FEI: 3006581049 • Il-Mosta, Mosta • MALTA
FEI Number
3006581049
Location
Il-Mosta, Mosta
Country
MALTAAddress
Sorbonne Centre F20, 5 Techno Park, Il-Mosta, Mosta, Malta
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2013 | 80MMPCOVER, BARRIER, PROTECTIVE | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 8/15/2013 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 8/15/2013 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 3280FRNMFGREG | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Microtek Medical Malta Limited's FDA import refusal history?
Microtek Medical Malta Limited (FEI: 3006581049) has 3 FDA import refusal record(s) in our database, spanning from 8/15/2013 to 8/15/2013.
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. Microtek Medical Malta Limited's FEI number is 3006581049.
What types of violations has Microtek Medical Malta Limited received?
Microtek Medical Malta Limited 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 Microtek Medical Malta Limited come from?
All FDA import refusal data for Microtek Medical Malta Limited 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.