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SPD SWISS PRECISION DIAGNOSTICS GMBH

✅ Low Risk

FEI: 3006635320 • Petit-Lancy, Geneva • SWITZERLAND

FEI

FEI Number

3006635320

📍

Location

Petit-Lancy, Geneva

🇨🇭
🏢

Address

C/O Proctor & Gamble, Route De Saint-Georges 47, Petit-Lancy, Geneva, Switzerland

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
3/5/2012
Latest Refusal
3/5/2012
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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

DateProductViolationsDivision
3/5/2012
75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SPD SWISS PRECISION DIAGNOSTICS GMBH's FDA import refusal history?

SPD SWISS PRECISION DIAGNOSTICS GMBH (FEI: 3006635320) has 1 FDA import refusal record(s) in our database, spanning from 3/5/2012 to 3/5/2012.

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. SPD SWISS PRECISION DIAGNOSTICS GMBH's FEI number is 3006635320.

What types of violations has SPD SWISS PRECISION DIAGNOSTICS GMBH received?

SPD SWISS PRECISION DIAGNOSTICS GMBH has been cited for 1 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 SPD SWISS PRECISION DIAGNOSTICS GMBH come from?

All FDA import refusal data for SPD SWISS PRECISION DIAGNOSTICS 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.