Wyeth Laboratories
⚠️ Moderate Risk
FEI: 1000207156 • Maidenhead • UNITED KINGDOM
FEI Number
1000207156
Location
Maidenhead
Country
UNITED KINGDOMAddress
Huntercombe Lane South Taplow, , Maidenhead, , United Kingdom
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).
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 |
|---|---|---|---|
| 8/15/2006 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/21/2005 | 62TCB02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2004 | 80FLKTHERMOMETER, CLINICAL MERCURY | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 8/15/2002 | 62TLC02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wyeth Laboratories's FDA import refusal history?
Wyeth Laboratories (FEI: 1000207156) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2002 to 8/15/2006.
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 Laboratories's FEI number is 1000207156.
What types of violations has Wyeth Laboratories received?
Wyeth Laboratories 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 Laboratories come from?
All FDA import refusal data for Wyeth Laboratories 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.