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Diesse Diagnostica Senese S.R.L.

⚠️ Moderate Risk

FEI: 1000186023 • Milano, MI • ITALY

FEI

FEI Number

1000186023

📍

Location

Milano, MI

🇮🇹

Country

ITALY
🏢

Address

Via S. Vittore, 36/1, , Milano, MI, Italy

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/28/2006
Latest Refusal
2/14/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

3412×

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).

5082×

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

DateProductViolationsDivision
3/28/2006
83LTWSUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)
2/14/2006
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Diesse Diagnostica Senese S.R.L.'s FDA import refusal history?

Diesse Diagnostica Senese S.R.L. (FEI: 1000186023) has 2 FDA import refusal record(s) in our database, spanning from 2/14/2006 to 3/28/2006.

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. Diesse Diagnostica Senese S.R.L.'s FEI number is 1000186023.

What types of violations has Diesse Diagnostica Senese S.R.L. received?

Diesse Diagnostica Senese S.R.L. 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 Diesse Diagnostica Senese S.R.L. come from?

All FDA import refusal data for Diesse Diagnostica Senese S.R.L. 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.