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Sabokay Industries

⚠️ Moderate Risk

FEI: 3002769835 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3002769835

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Jummu Road, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/22/2005
Latest Refusal
11/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
16.3×10%
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

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).

3412×

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

DateProductViolationsDivision
9/22/2005
76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL
290DE IMP GMP
341REGISTERED
Florida District Office (FLA-DO)
4/27/2005
76EISREMOVER, CROWN
341REGISTERED
Florida District Office (FLA-DO)
11/18/2003
85HDFSPECULUM, VAGINAL, METAL
290DE IMP GMP
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sabokay Industries's FDA import refusal history?

Sabokay Industries (FEI: 3002769835) has 3 FDA import refusal record(s) in our database, spanning from 11/18/2003 to 9/22/2005.

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. Sabokay Industries's FEI number is 3002769835.

What types of violations has Sabokay Industries received?

Sabokay Industries 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 Sabokay Industries come from?

All FDA import refusal data for Sabokay Industries 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.