Pfizer Egypt Saa
⚠️ Moderate Risk
FEI: 3003337198 • Al Qahira, Al Qahira • EGYPT
FEI Number
3003337198
Location
Al Qahira, Al Qahira
Country
EGYPTAddress
El-Thoura St Almaza Heliopolis, , Al Qahira, Al Qahira, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2011 | 64MCA01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/21/2007 | 62CDB14DEBRISOQUIN SULFATE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/23/2007 | 61PDP09GLIPIZIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/16/2004 | 61NCP99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/16/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pfizer Egypt Saa's FDA import refusal history?
Pfizer Egypt Saa (FEI: 3003337198) has 5 FDA import refusal record(s) in our database, spanning from 12/16/2004 to 10/25/2011.
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. Pfizer Egypt Saa's FEI number is 3003337198.
What types of violations has Pfizer Egypt Saa received?
Pfizer Egypt Saa 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 Pfizer Egypt Saa come from?
All FDA import refusal data for Pfizer Egypt Saa 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.