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Perfectra Instruments

Low Risk

FEI: 3003128247 • Sialkot • PAKISTAN

FEI

FEI Number

3003128247

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Pacca Garh, , Sialkot, , Pakistan

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/3/2002
Latest Refusal
1/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
1/3/2002
79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE
2780DEVICEGMPS
333LACKS FIRM
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Perfectra Instruments's FDA import refusal history?

Perfectra Instruments (FEI: 3003128247) has 1 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 1/3/2002.

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. Perfectra Instruments's FEI number is 3003128247.

What types of violations has Perfectra Instruments received?

Perfectra Instruments 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 Perfectra Instruments come from?

All FDA import refusal data for Perfectra Instruments 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.