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RISTEK INSTRUMENT

⚠️ Moderate Risk

FEI: 3013453738 • Sialkot Cantt • PAKISTAN

FEI

FEI Number

3013453738

📍

Location

Sialkot Cantt

🇵🇰

Country

PAKISTAN
🏢

Address

93/5 Aziz Shaheed Road, , Sialkot Cantt, , Pakistan

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/6/2017
Latest Refusal
6/6/2017
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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

DateProductViolationsDivision
6/6/2017
76NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
2780DEVICEGMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is RISTEK INSTRUMENT's FDA import refusal history?

RISTEK INSTRUMENT (FEI: 3013453738) has 1 FDA import refusal record(s) in our database, spanning from 6/6/2017 to 6/6/2017.

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. RISTEK INSTRUMENT's FEI number is 3013453738.

What types of violations has RISTEK INSTRUMENT received?

RISTEK INSTRUMENT 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 RISTEK INSTRUMENT come from?

All FDA import refusal data for RISTEK INSTRUMENT 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.