ImportRefusal LogoImportRefusal

Ups Scs (Czech Republik) S.R.O.

⚠️ Moderate Risk

FEI: 3008361298 • Praha • CZECH REPUBLIC

FEI

FEI Number

3008361298

📍

Location

Praha

🇨🇿
🏢

Address

Stochovska 1057/80, , Praha, , Czech Republic

Moderate Risk

FDA Import Risk Assessment

35.2
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
2/8/2011
Latest Refusal
11/5/2010
Earliest Refusal

Score Breakdown

Violation Severity
58.6×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

5083×

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
2/8/2011
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
11/5/2010
79GDWSTAPLE, IMPLANTABLE
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/5/2010
79LFLINSTRUMENT, ULTRASONIC SURGICAL
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
11/5/2010
79GDWSTAPLE, IMPLANTABLE
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ups Scs (Czech Republik) S.R.O.'s FDA import refusal history?

Ups Scs (Czech Republik) S.R.O. (FEI: 3008361298) has 4 FDA import refusal record(s) in our database, spanning from 11/5/2010 to 2/8/2011.

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. Ups Scs (Czech Republik) S.R.O.'s FEI number is 3008361298.

What types of violations has Ups Scs (Czech Republik) S.R.O. received?

Ups Scs (Czech Republik) S.R.O. 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 Ups Scs (Czech Republik) S.R.O. come from?

All FDA import refusal data for Ups Scs (Czech Republik) S.R.O. 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.