ImportRefusal LogoImportRefusal

Rafi Systems Ltd Abedin Tower

⚠️ Moderate Risk

FEI: 3003505610 • Banani Dhaka Bangladesh • BANGLADESH

FEI

FEI Number

3003505610

📍

Location

Banani Dhaka Bangladesh

🇧🇩

Country

BANGLADESH
🏢

Address

35 Kemal Adadurk Ave, , Banani Dhaka Bangladesh, , Bangladesh

Moderate Risk

FDA Import Risk Assessment

30.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/20/2007
Latest Refusal
12/13/2006
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/20/2007
86LZPAID, SURGICAL, VISCOELASTIC
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
12/13/2006
86LZPAID, SURGICAL, VISCOELASTIC
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Rafi Systems Ltd Abedin Tower's FDA import refusal history?

Rafi Systems Ltd Abedin Tower (FEI: 3003505610) has 2 FDA import refusal record(s) in our database, spanning from 12/13/2006 to 3/20/2007.

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. Rafi Systems Ltd Abedin Tower's FEI number is 3003505610.

What types of violations has Rafi Systems Ltd Abedin Tower received?

Rafi Systems Ltd Abedin Tower 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 Rafi Systems Ltd Abedin Tower come from?

All FDA import refusal data for Rafi Systems Ltd Abedin Tower 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.