Wyeth Farma SA
⚠️ Moderate Risk
FEI: 3003973260 • San Sebastian De Los Reyes, Madrid • SPAIN
FEI Number
3003973260
Location
San Sebastian De Los Reyes, Madrid
Country
SPAINAddress
Autovia Del Norte A-1 Km 23 Desvio Algete, Km 1, , San Sebastian De Los Reyes, Madrid, Spain
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2010 | 62IDA23FLUOROURACIL (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/12/2010 | 62IDA23FLUOROURACIL (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 66MCA86LORAZEPAM (TRANQUILIZER) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Wyeth Farma SA's FDA import refusal history?
Wyeth Farma SA (FEI: 3003973260) has 4 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 11/12/2010.
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. Wyeth Farma SA's FEI number is 3003973260.
What types of violations has Wyeth Farma SA received?
Wyeth Farma SA 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 Wyeth Farma SA come from?
All FDA import refusal data for Wyeth Farma SA 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.