OBER CONSULTING POLAND SP. Z O.O
⚠️ Moderate Risk
FEI: 3013325496 • Poznan, Wielkopolskie • POLAND
FEI Number
3013325496
Location
Poznan, Wielkopolskie
Country
POLANDAddress
Brzechwy 6 60-195 Pozna, , Poznan, Wielkopolskie, Poland
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/8/2015 | 86HMCMONITOR, EYE MOVEMENT, DIAGNOSTIC | Cincinnati District Office (CIN-DO) | |
| 6/4/2015 | 86HQFLASER, OPHTHALMIC | Cincinnati District Office (CIN-DO) | |
| 6/3/2015 | 86HLLMONITOR, EYE MOVEMENT | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is OBER CONSULTING POLAND SP. Z O.O's FDA import refusal history?
OBER CONSULTING POLAND SP. Z O.O (FEI: 3013325496) has 3 FDA import refusal record(s) in our database, spanning from 6/3/2015 to 6/8/2015.
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. OBER CONSULTING POLAND SP. Z O.O's FEI number is 3013325496.
What types of violations has OBER CONSULTING POLAND SP. Z O.O received?
OBER CONSULTING POLAND SP. Z O.O has been cited for 6 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 OBER CONSULTING POLAND SP. Z O.O come from?
All FDA import refusal data for OBER CONSULTING POLAND SP. Z O.O 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.