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Good Health

⚠️ Moderate Risk

FEI: 3004499770 • Chester • UNITED KINGDOM

FEI

FEI Number

3004499770

📍

Location

Chester

🇬🇧
🏢

Address

291 Chester Rd, , Chester, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/21/2004
Latest Refusal
5/21/2004
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

23802×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

DateProductViolationsDivision
5/21/2004
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
2380NO PMA/PDP
New Orleans District Office (NOL-DO)
5/21/2004
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
2380NO PMA/PDP
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Good Health's FDA import refusal history?

Good Health (FEI: 3004499770) has 2 FDA import refusal record(s) in our database, spanning from 5/21/2004 to 5/21/2004.

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. Good Health's FEI number is 3004499770.

What types of violations has Good Health received?

Good Health 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 Good Health come from?

All FDA import refusal data for Good Health 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.