Amoun Pharmaceutical Company
⚠️ Moderate Risk
FEI: 3006512892 • Cairo • EGYPT
FEI Number
3006512892
Location
Cairo
Country
EGYPTAddress
1st Industrial Zone, Cairo Ismailia Road, , El-Obour City, Cairo, , Egypt
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/23/2014 | 56DDK99AMINOGLYCOSIDES, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/23/2014 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2011 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 62OAA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/10/2008 | 66YCB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/10/2008 | 66YCB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/10/2008 | 66YCB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/6/2006 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 488HEALTH C | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amoun Pharmaceutical Company's FDA import refusal history?
Amoun Pharmaceutical Company (FEI: 3006512892) has 9 FDA import refusal record(s) in our database, spanning from 12/6/2006 to 5/21/2015.
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. Amoun Pharmaceutical Company's FEI number is 3006512892.
What types of violations has Amoun Pharmaceutical Company received?
Amoun Pharmaceutical Company 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 Amoun Pharmaceutical Company come from?
All FDA import refusal data for Amoun Pharmaceutical Company 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.