PXD System
⚠️ Moderate Risk
FEI: 3006851457 • Skopje, MK-NA • MACEDONIA
FEI Number
3006851457
Location
Skopje, MK-NA
Country
MACEDONIAAddress
Leninova 79, , Skopje, MK-NA, Macedonia
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 7/30/2009 | 89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 7/30/2009 | 89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 7/30/2009 | 28CYT99NATURAL EXTRACT OR FLAVOR, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is PXD System's FDA import refusal history?
PXD System (FEI: 3006851457) has 3 FDA import refusal record(s) in our database, spanning from 7/30/2009 to 7/30/2009.
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. PXD System's FEI number is 3006851457.
What types of violations has PXD System received?
PXD System 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 PXD System come from?
All FDA import refusal data for PXD System 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.