OLA Olsen EFTF A.S.
⚠️ Moderate Risk
FEI: 1000182170 • Stavanger • NORWAY
FEI Number
1000182170
Location
Stavanger
Country
NORWAYAddress
Lyder Sagenst 4015, , Stavanger, , Norway
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2010 | 85HDYDILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/18/2010 | 85HDYDILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/6/2010 | 85HDYDILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is OLA Olsen EFTF A.S.'s FDA import refusal history?
OLA Olsen EFTF A.S. (FEI: 1000182170) has 3 FDA import refusal record(s) in our database, spanning from 1/6/2010 to 3/18/2010.
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. OLA Olsen EFTF A.S.'s FEI number is 1000182170.
What types of violations has OLA Olsen EFTF A.S. received?
OLA Olsen EFTF A.S. 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 OLA Olsen EFTF A.S. come from?
All FDA import refusal data for OLA Olsen EFTF A.S. 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.