Bohus Biotech Ab
⚠️ Moderate Risk
FEI: 3002243975 • Stromstad, Vastra Gotalands Lan • SWEDEN
FEI Number
3002243975
Location
Stromstad, Vastra Gotalands Lan
Country
SWEDENAddress
Uddevallavagen 3, , Stromstad, Vastra Gotalands Lan, Sweden
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 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).
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 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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/1/2006 | 86LWLFLUID, INTRAOCULAR | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/2/2005 | 86LZPAID, SURGICAL, VISCOELASTIC | 237NO PMA | Los Angeles District Office (LOS-DO) |
| 8/2/2005 | 86LZPAID, SURGICAL, VISCOELASTIC | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 7/20/2004 | 68XAK10SMALL ANIMAL DEVICE/DIAG PROD FOR ANIMAL | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bohus Biotech Ab's FDA import refusal history?
Bohus Biotech Ab (FEI: 3002243975) has 4 FDA import refusal record(s) in our database, spanning from 7/20/2004 to 3/1/2006.
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. Bohus Biotech Ab's FEI number is 3002243975.
What types of violations has Bohus Biotech Ab received?
Bohus Biotech Ab has been cited for 4 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 Bohus Biotech Ab come from?
All FDA import refusal data for Bohus Biotech Ab 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.