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STAR FABRICS

⚠️ Moderate Risk

FEI: 3015906773 • Faisalabad, Punjab • PAKISTAN

FEI

FEI Number

3015906773

📍

Location

Faisalabad, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

119 Jb-Chak Samana Dhanola Road Off Sargodha Road, , Faisalabad, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

32.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/29/2020
Latest Refusal
8/19/2020
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
9/29/2020
80FYBGOWN, PATIENT
3280FRNMFGREG
Division of Southeast Imports (DSEI)
9/29/2020
80FYBGOWN, PATIENT
3280FRNMFGREG
Division of Southeast Imports (DSEI)
8/19/2020
80FYBGOWN, PATIENT
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is STAR FABRICS's FDA import refusal history?

STAR FABRICS (FEI: 3015906773) has 3 FDA import refusal record(s) in our database, spanning from 8/19/2020 to 9/29/2020.

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. STAR FABRICS's FEI number is 3015906773.

What types of violations has STAR FABRICS received?

STAR FABRICS 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 STAR FABRICS come from?

All FDA import refusal data for STAR FABRICS 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.