Seton Healthcare Group
⚠️ Moderate Risk
FEI: 1000164985 • Oldham • UNITED KINGDOM
FEI Number
1000164985
Location
Oldham
Country
UNITED KINGDOMAddress
Tubiton House, , Oldham, , 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
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/21/2005 | 65RAY18SODIUM BICARBONATE (REPLENISHER) | 473LABELING | New York District Office (NYK-DO) |
| 10/28/2003 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/17/2003 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/6/2002 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/18/2002 | 66VNY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/7/2002 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/8/2002 | 29WYY99WATER AND ICE, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Seton Healthcare Group's FDA import refusal history?
Seton Healthcare Group (FEI: 1000164985) has 7 FDA import refusal record(s) in our database, spanning from 4/8/2002 to 9/21/2005.
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. Seton Healthcare Group's FEI number is 1000164985.
What types of violations has Seton Healthcare Group received?
Seton Healthcare Group 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 Seton Healthcare Group come from?
All FDA import refusal data for Seton Healthcare Group 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.