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Micromech Inst Cor'P

⚠️ Moderate Risk

FEI: 3003589434 • Sialkot • PAKISTAN

FEI

FEI Number

3003589434

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

P O Box No 816, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

36.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/13/2002
Latest Refusal
4/12/2002
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

27802×

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.

4801×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

Refusal History

DateProductViolationsDivision
4/13/2002
80LDQDEVICE, GENERAL MEDICAL
2780DEVICEGMPS
Cincinnati District Office (CIN-DO)
4/12/2002
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
2780DEVICEGMPS
480STAINSTEEL
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Micromech Inst Cor'P's FDA import refusal history?

Micromech Inst Cor'P (FEI: 3003589434) has 2 FDA import refusal record(s) in our database, spanning from 4/12/2002 to 4/13/2002.

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. Micromech Inst Cor'P's FEI number is 3003589434.

What types of violations has Micromech Inst Cor'P received?

Micromech Inst Cor'P 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 Micromech Inst Cor'P come from?

All FDA import refusal data for Micromech Inst Cor'P 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.