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MEDITECH INDUSTRY

⚠️ Moderate Risk

FEI: 3015086835 • Siaklot • PAKISTAN

FEI

FEI Number

3015086835

📍

Location

Siaklot

🇵🇰

Country

PAKISTAN
🏢

Address

Sublime Chowk Malkay Kalan, Near Syeda Ayesha Girls High School, Siaklot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/21/2019
Latest Refusal
2/21/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27803×

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

DateProductViolationsDivision
2/21/2019
76EIFACCESSORIES, RETRACTOR, DENTAL
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)
2/21/2019
76EIFACCESSORIES, RETRACTOR, DENTAL
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)
2/21/2019
76EIFACCESSORIES, RETRACTOR, DENTAL
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MEDITECH INDUSTRY's FDA import refusal history?

MEDITECH INDUSTRY (FEI: 3015086835) has 3 FDA import refusal record(s) in our database, spanning from 2/21/2019 to 2/21/2019.

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. MEDITECH INDUSTRY's FEI number is 3015086835.

What types of violations has MEDITECH INDUSTRY received?

MEDITECH INDUSTRY has been cited for 1 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 MEDITECH INDUSTRY come from?

All FDA import refusal data for MEDITECH INDUSTRY 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.