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AHAF SURGICO

⚠️ Moderate Risk

FEI: 3018283292 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3018283292

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Near City Public, , Sialkot, Punjab, 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

1
Total Refusals
1
Unique Violations
10/15/2021
Latest Refusal
10/15/2021
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
1.1×20%
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

2901×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

Refusal History

DateProductViolationsDivision
10/15/2021
76EKDINSTRUMENT, CUTTING, OPERATIVE
290DE IMP GMP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is AHAF SURGICO's FDA import refusal history?

AHAF SURGICO (FEI: 3018283292) has 1 FDA import refusal record(s) in our database, spanning from 10/15/2021 to 10/15/2021.

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. AHAF SURGICO's FEI number is 3018283292.

What types of violations has AHAF SURGICO received?

AHAF SURGICO 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 AHAF SURGICO come from?

All FDA import refusal data for AHAF SURGICO 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.