Seroyal, International
⚠️ Moderate Risk
FEI: 3002662149 • Richmond Hill, Ontario • CANADA
FEI Number
3002662149
Location
Richmond Hill, Ontario
Country
CANADAAddress
490 Elgin Mills Rd E, , Richmond Hill, Ontario, Canada
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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
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 |
|---|---|---|---|
| 8/6/2013 | 54ECL99HERBALS & BOTANICAL TEAS, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/1/2005 | 54ABA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 10/22/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/2/2003 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Cincinnati District Office (CIN-DO) |
| 10/2/2003 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Seroyal, International's FDA import refusal history?
Seroyal, International (FEI: 3002662149) has 7 FDA import refusal record(s) in our database, spanning from 10/2/2003 to 8/6/2013.
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. Seroyal, International's FEI number is 3002662149.
What types of violations has Seroyal, International received?
Seroyal, International 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 Seroyal, International come from?
All FDA import refusal data for Seroyal, International 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.