Four M Import & Export

⚠️ Moderate Risk

FEI: 3007915521 • Cairo, Cairo • EGYPT

FEI

FEI Number

3007915521

📍

Location

Cairo, Cairo

🇪🇬

Country

EGYPT

🏢

Address

4 Kassem Esmaail St, El-Attar, Egypt, Cairo, Cairo, Egypt

Moderate Risk

FDA Import Risk Assessment

42.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/12/2013

Latest Refusal

6/3/2010

Earliest Refusal

Score Breakdown

Violation Severity

82.9×40%

Refusal Volume

25.9×30%

Recency

0.0×20%

Frequency

14.8×10%

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

Violation Summary

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

Date	Product	Violations	Division
2/12/2013	21VCT05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
6/3/2010	21TFT14TAMARIND, DRIED OR PASTE	249FILTHY	New York District Office (NYK-DO)
6/3/2010	66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
6/3/2010	66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Four M Import & Export's FDA import refusal history?

Four M Import & Export (FEI: 3007915521) has 4 FDA import refusal record(s) in our database, spanning from 6/3/2010 to 2/12/2013.

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. Four M Import & Export's FEI number is 3007915521.

What types of violations has Four M Import & Export received?

Four M Import & Export has been cited for 5 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 Four M Import & Export come from?

All FDA import refusal data for Four M 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.