DiaMed GmbH

⚠️ Moderate Risk

FEI: 3004910133 • Cressier Fr, Friburg • SWITZERLAND

FEI

FEI Number

3004910133

📍

Location

Cressier Fr, Friburg

🇨🇭

Country

SWITZERLAND

🏢

Address

Route Du Pra-Rond 23, , Cressier Fr, Friburg, Switzerland

Moderate Risk

FDA Import Risk Assessment

41.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

9/14/2011

Latest Refusal

11/28/2005

Earliest Refusal

Score Breakdown

Violation Severity

67.8×40%

Refusal Volume

41.3×30%

Recency

0.0×20%

Frequency

20.7×10%

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

Violation Summary

1186×

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).

716×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

5085×

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.

3411×

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
9/14/2011	81GIFDILUENT, BLOOD CELL	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
9/14/2011	81KSNCENTRIFUGE, CELL-WASHING, AUTOMATED FOR IMMUNO-HEMATOLOGY	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
9/14/2011	81GIFDILUENT, BLOOD CELL	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
9/14/2011	81MVUREAGENTS, SPECIFIC, ANALYTE	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
3/11/2011	81GIFDILUENT, BLOOD CELL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
11/6/2009	57FG22ANTI-M (HUMAN) (BLOOD GROUPING SERUM)	71NO LICENSE	New Orleans District Office (NOL-DO)
11/6/2009	57FG38ANTI-S (BLOOD GROUPING SERUM)	71NO LICENSE	New Orleans District Office (NOL-DO)
11/6/2009	57FG38ANTI-S (BLOOD GROUPING SERUM)	71NO LICENSE	New Orleans District Office (NOL-DO)
11/6/2009	57FG01ANTI-A1 (BLOOD GROUPING SERUM)	71NO LICENSE	New Orleans District Office (NOL-DO)
11/6/2009	57FG07ANTI-FYB (BLOOD GROUPING SERUM)	71NO LICENSE	New Orleans District Office (NOL-DO)
11/28/2005	83GMQANTIGENS, NONTREPONEMAL, ALL	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
11/28/2005	57FB28ANTI-D (HIGH PROTEIN) (BLOOD GROUPING SERUM)	71NO LICENSE	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is DiaMed GmbH's FDA import refusal history?

DiaMed GmbH (FEI: 3004910133) has 12 FDA import refusal record(s) in our database, spanning from 11/28/2005 to 9/14/2011.

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. DiaMed GmbH's FEI number is 3004910133.

What types of violations has DiaMed GmbH received?

DiaMed GmbH 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 DiaMed GmbH come from?

All FDA import refusal data for DiaMed GmbH 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.