Solatch International

⚠️ Moderate Risk

FEI: 3002914520 • Sialkot • PAKISTAN

FEI

FEI Number

3002914520

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

Wazirabad Road, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

41.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/15/2012

Latest Refusal

2/23/2006

Earliest Refusal

Score Breakdown

Violation Severity

78.3×40%

Refusal Volume

31.3×30%

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

Violation Summary

4805×

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.

27801×

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.

Refusal History

Date	Product	Violations	Division
2/15/2012	78FHQHOLDER, NEEDLE	480STAINSTEEL	New York District Office (NYK-DO)
2/15/2012	79HTDFORCEPS	480STAINSTEEL	New York District Office (NYK-DO)
2/15/2012	80JOKSCISSORS, MEDICAL, DISPOSABLE	480STAINSTEEL	New York District Office (NYK-DO)
2/23/2006	87HRRSCISSORS	2780DEVICEGMPS	New York District Office (NYK-DO)
2/23/2006	79HTDFORCEPS	480STAINSTEEL	New York District Office (NYK-DO)
2/23/2006	78FHQHOLDER, NEEDLE	480STAINSTEEL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Solatch International's FDA import refusal history?

Solatch International (FEI: 3002914520) has 6 FDA import refusal record(s) in our database, spanning from 2/23/2006 to 2/15/2012.

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. Solatch International's FEI number is 3002914520.

What types of violations has Solatch International received?

Solatch International 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 Solatch International come from?

All FDA import refusal data for Solatch International 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.