G B Medical Ltd

⚠️ Moderate Risk

FEI: 3005259373 • Hamshire • UNITED KINGDOM

FEI

FEI Number

3005259373

📍

Location

Hamshire

🇬🇧

Country

UNITED KINGDOM

🏢

Address

2 Edison Gate, West Portway Indust, , Andover, Hamshire, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

34.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/19/2012

Latest Refusal

12/9/2011

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

80.0×10%

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

Violation Summary

1188×

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).

3418×

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

Date	Product	Violations	Division
7/19/2012	79GEHUNIT, CRYOSURGICAL, ACCESSORIES	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	87HWCSCREW, FIXATION, BONE	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	87HWXTAP, BONE	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	87HXXSCREWDRIVER	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	87HWAIMPACTOR	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	79GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	87HTWBIT, DRILL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
12/9/2011	79GENFORCEPS, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)

Frequently Asked Questions

What is G B Medical Ltd's FDA import refusal history?

G B Medical Ltd (FEI: 3005259373) has 8 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 7/19/2012.

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. G B Medical Ltd's FEI number is 3005259373.

What types of violations has G B Medical Ltd received?

G B Medical Ltd 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 G B Medical Ltd come from?

All FDA import refusal data for G B Medical Ltd 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.