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Suarna Bakit Corpo

⚠️ Moderate Risk

FEI: 3009936130 • Sialkot • PAKISTAN

FEI

FEI Number

3009936130

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

H 21 198 Chah Ja, , Sialkot, , 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

1
Total Refusals
2
Unique Violations
2/4/2013
Latest Refusal
2/4/2013
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
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

© ImportRefusal.com Original Analysis

Violation Summary

1181×

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).

2901×

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).

Refusal History

DateProductViolationsDivision
2/4/2013
76JEXPLIER, ORTHODONTIC
118NOT LISTED
290DE IMP GMP
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Suarna Bakit Corpo's FDA import refusal history?

Suarna Bakit Corpo (FEI: 3009936130) has 1 FDA import refusal record(s) in our database, spanning from 2/4/2013 to 2/4/2013.

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. Suarna Bakit Corpo's FEI number is 3009936130.

What types of violations has Suarna Bakit Corpo received?

Suarna Bakit Corpo 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 Suarna Bakit Corpo come from?

All FDA import refusal data for Suarna Bakit Corpo 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.