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Ghassan Ali Al Ama

⚠️ Moderate Risk

FEI: 3007176448 • Sana'A • YEMEN

FEI

FEI Number

3007176448

📍

Location

Sana'A

🇾🇪

Country

YEMEN
🏢

Address

Al Qadissyah Stree, , Sana'A, , Yemen

Moderate Risk

FDA Import Risk Assessment

47.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/10/2008
Latest Refusal
11/10/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

754×

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).

Refusal History

DateProductViolationsDivision
11/10/2008
62TCC07PANTOPRAZOLE SODIUM
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/10/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/10/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/10/2008
61NDC55SULPIRIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ghassan Ali Al Ama's FDA import refusal history?

Ghassan Ali Al Ama (FEI: 3007176448) has 4 FDA import refusal record(s) in our database, spanning from 11/10/2008 to 11/10/2008.

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. Ghassan Ali Al Ama's FEI number is 3007176448.

What types of violations has Ghassan Ali Al Ama received?

Ghassan Ali Al Ama 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 Ghassan Ali Al Ama come from?

All FDA import refusal data for Ghassan Ali Al Ama 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.