Goldstar Medical Instruments

⚠️ Moderate Risk

FEI: 3000126234 • Sialkot • PAKISTAN

FEI

FEI Number

3000126234

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

Hayat Centre, Khadim Ali Road, Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

45.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/7/2012

Latest Refusal

6/15/2009

Earliest Refusal

Score Breakdown

Violation Severity

74.6×40%

Refusal Volume

41.3×30%

Recency

0.0×20%

Frequency

37.1×10%

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

4808×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

27802×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

2902×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

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

Date	Product	Violations	Division
9/7/2012	73CCWLARYNGOSCOPE, RIGID	290DE IMP GMP	New Orleans District Office (NOL-DO)
5/31/2012	73CCWLARYNGOSCOPE, RIGID	290DE IMP GMP 341REGISTERED	New Orleans District Office (NOL-DO)
10/15/2010	73CCWLARYNGOSCOPE, RIGID	480STAINSTEEL	New York District Office (NYK-DO)
8/30/2010	73CCWLARYNGOSCOPE, RIGID	480STAINSTEEL	New York District Office (NYK-DO)
6/25/2009	77EQNLARYNGOSCOPE	480STAINSTEEL	New York District Office (NYK-DO)
6/25/2009	77EQNLARYNGOSCOPE	480STAINSTEEL	New York District Office (NYK-DO)
6/25/2009	77EQNLARYNGOSCOPE	480STAINSTEEL	New York District Office (NYK-DO)
6/25/2009	77EQNLARYNGOSCOPE	480STAINSTEEL	New York District Office (NYK-DO)
6/25/2009	77EQNLARYNGOSCOPE	480STAINSTEEL	New York District Office (NYK-DO)
6/25/2009	77EQNLARYNGOSCOPE	480STAINSTEEL	New York District Office (NYK-DO)
6/15/2009	73CCWLARYNGOSCOPE, RIGID	2780DEVICEGMPS	Southwest Import District Office (SWI-DO)
6/15/2009	73CCWLARYNGOSCOPE, RIGID	2780DEVICEGMPS	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Goldstar Medical Instruments's FDA import refusal history?

Goldstar Medical Instruments (FEI: 3000126234) has 12 FDA import refusal record(s) in our database, spanning from 6/15/2009 to 9/7/2012.

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. Goldstar Medical Instruments's FEI number is 3000126234.

What types of violations has Goldstar Medical Instruments received?

Goldstar Medical Instruments has been cited for 4 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 Goldstar Medical Instruments come from?

All FDA import refusal data for Goldstar Medical Instruments 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.