Orion Health Corp
⚠️ Moderate Risk
FEI: 3003451509 • Margate • UNITED KINGDOM
FEI Number
3003451509
Location
Margate
Country
UNITED KINGDOMAddress
Orion Hse 7 Lindhurt Avenue, , Margate, , 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
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.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2001 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/27/2001 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/27/2001 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/27/2001 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/16/2001 | 54AYY99VITAMIN, N.E.C. | 320LACKS FIRM | New Orleans District Office (NOL-DO) |
| 10/19/2001 | 54AYY90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Orion Health Corp's FDA import refusal history?
Orion Health Corp (FEI: 3003451509) has 6 FDA import refusal record(s) in our database, spanning from 10/19/2001 to 12/18/2001.
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. Orion Health Corp's FEI number is 3003451509.
What types of violations has Orion Health Corp received?
Orion Health Corp has been cited for 4 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 Orion Health Corp come from?
All FDA import refusal data for Orion Health Corp 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.