Wyeth Hellas S.A.
⚠️ Moderate Risk
FEI: 3005780722 • Athensathens • GREECE
FEI Number
3005780722
Location
Athensathens
Country
GREECEAddress
126 Kyprou Aveargyrourolis, , Athensathens, , Greece
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2006 | 75CGAGLUCOSE OXIDASE, GLUCOSE | New York District Office (NYK-DO) | |
| 8/11/2006 | 61PCB26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/11/2006 | 61PCB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/11/2006 | 62OCB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/11/2006 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wyeth Hellas S.A.'s FDA import refusal history?
Wyeth Hellas S.A. (FEI: 3005780722) has 5 FDA import refusal record(s) in our database, spanning from 8/11/2006 to 8/11/2006.
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 Hellas S.A.'s FEI number is 3005780722.
What types of violations has Wyeth Hellas S.A. received?
Wyeth Hellas S.A. has been cited for 3 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 Hellas S.A. come from?
All FDA import refusal data for Wyeth Hellas S.A. 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.