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El Hamd Co For Import & Export

⚠️ Moderate Risk

FEI: 3004150452 • Al Qahira, Al Qahira • EGYPT

FEI

FEI Number

3004150452

📍

Location

Al Qahira, Al Qahira

🇪🇬

Country

EGYPT
🏢

Address

3 Ahmed Reaad Hams St, , Al Qahira, Al Qahira, Egypt

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
10/3/2003
Latest Refusal
10/3/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

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).

5081×

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.

Refusal History

DateProductViolationsDivision
10/3/2003
76EFWTOOTHBRUSH, MANUAL
238UNSAFE ADD
Cincinnati District Office (CIN-DO)
10/3/2003
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
508NO 510(K)
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is El Hamd Co For Import & Export's FDA import refusal history?

El Hamd Co For Import & Export (FEI: 3004150452) has 2 FDA import refusal record(s) in our database, spanning from 10/3/2003 to 10/3/2003.

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. El Hamd Co For Import & Export's FEI number is 3004150452.

What types of violations has El Hamd Co For Import & Export received?

El Hamd Co For Import & Export has been cited for 4 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 El Hamd Co For Import & Export come from?

All FDA import refusal data for El Hamd Co For Import & Export 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.