Cbm Srl Officine Metalmeccaniche

⚠️ Moderate Risk

FEI: 3005171252 • Cremona, Cremona • ITALY

FEI

FEI Number

3005171252

📍

Location

Cremona, Cremona

🇮🇹

Country

ITALY

🏢

Address

Via Galeazzo Sommi Picenardi 26038, , Cremona, Cremona, Italy

Moderate Risk

FDA Import Risk Assessment

43.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/1/2006

Latest Refusal

7/20/2005

Earliest Refusal

Score Breakdown

Violation Severity

46.5×40%

Refusal Volume

49.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

34120×

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).

50814×

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.

Refusal History

Date	Product	Violations	Division
3/1/2006	78EYDSTIRRUPS	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/1/2006	80KMNCHAIR AND TABLE, MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/1/2006	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/1/2006	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/1/2006	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/5/2006	78EYDSTIRRUPS	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/5/2006	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED	Florida District Office (FLA-DO)
12/29/2005	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/29/2005	78EYDSTIRRUPS	341REGISTERED	Florida District Office (FLA-DO)
12/27/2005	80KMNCHAIR AND TABLE, MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/27/2005	80KMNCHAIR AND TABLE, MEDICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/27/2005	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/17/2005	78EYDSTIRRUPS	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/17/2005	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/20/2005	80FNJBED, MANUAL	341REGISTERED	Division of Southeast Imports (DSEI)
7/20/2005	80FNYBASIN, EMESIS	341REGISTERED	Division of Southeast Imports (DSEI)
7/20/2005	80FOXSTAND, INFUSION	341REGISTERED	Division of Southeast Imports (DSEI)
7/20/2005	79FSMTRAY, SURGICAL, INSTRUMENT	341REGISTERED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Cbm Srl Officine Metalmeccaniche's FDA import refusal history?

Cbm Srl Officine Metalmeccaniche (FEI: 3005171252) has 20 FDA import refusal record(s) in our database, spanning from 7/20/2005 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. Cbm Srl Officine Metalmeccaniche's FEI number is 3005171252.

What types of violations has Cbm Srl Officine Metalmeccaniche received?

Cbm Srl Officine Metalmeccaniche 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 Cbm Srl Officine Metalmeccaniche come from?

All FDA import refusal data for Cbm Srl Officine Metalmeccaniche 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.