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Wyeth Medica Ireland

⚠️ Moderate Risk

FEI: 3006796068 • Kildare, Co. KILDARE • IRELAND

FEI

FEI Number

3006796068

📍

Location

Kildare, Co. KILDARE

🇮🇪

Country

IRELAND
🏢

Address

Little Connel New Bridge, , Kildare, Co. KILDARE, Ireland

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
10/27/2011
Latest Refusal
10/22/2002
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
5.5×10%
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

755×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
10/27/2011
64GDB27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN)
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/12/2006
64GIS07ESTRADIOL (ESTROGEN)
75UNAPPROVED
New York District Office (NYK-DO)
6/12/2006
64GIS29LEVONORGESTREL (ESTROGEN)
75UNAPPROVED
New York District Office (NYK-DO)
11/8/2004
60PIY99ANETHESIA ADJUNCT, N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
10/22/2002
64GDA29LEVONORGESTREL (ESTROGEN)
75UNAPPROVED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Wyeth Medica Ireland's FDA import refusal history?

Wyeth Medica Ireland (FEI: 3006796068) has 5 FDA import refusal record(s) in our database, spanning from 10/22/2002 to 10/27/2011.

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. Wyeth Medica Ireland's FEI number is 3006796068.

What types of violations has Wyeth Medica Ireland received?

Wyeth Medica Ireland 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 Medica Ireland come from?

All FDA import refusal data for Wyeth Medica Ireland 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.