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HIGHTECH DEVELOPMENT, S.R.O.

⚠️ Moderate Risk

FEI: 3015363546 • Prague 4 • CZECH REPUBLIC

FEI

FEI Number

3015363546

📍

Location

Prague 4

🇨🇿
🏢

Address

Mecislavova 414/11, , Prague 4, , Czech Republic

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/15/2019
Latest Refusal
7/15/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
7/15/2019
89EGJDEVICE, IONTOPHORESIS, OTHER USES
2480RXPERSONAL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HIGHTECH DEVELOPMENT, S.R.O.'s FDA import refusal history?

HIGHTECH DEVELOPMENT, S.R.O. (FEI: 3015363546) has 1 FDA import refusal record(s) in our database, spanning from 7/15/2019 to 7/15/2019.

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. HIGHTECH DEVELOPMENT, S.R.O.'s FEI number is 3015363546.

What types of violations has HIGHTECH DEVELOPMENT, S.R.O. received?

HIGHTECH DEVELOPMENT, S.R.O. 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 HIGHTECH DEVELOPMENT, S.R.O. come from?

All FDA import refusal data for HIGHTECH DEVELOPMENT, 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.