SILVERHEALTH PRODUCTS INC
⚠️ Moderate Risk
FEI: 2000006429 • Surrey, British Columbia • CANADA
FEI Number
2000006429
Location
Surrey, British Columbia
Country
CANADAAddress
10870 160a St, , Surrey, British Columbia, 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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/11/2006 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/11/2006 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/28/2005 | 62FCJ36SILVER NITRATE (ANTI-INFECTIVE, TOPICAL) | Seattle District Office (SEA-DO) | |
| 12/28/2005 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 12/27/2005 | 65FIK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is SILVERHEALTH PRODUCTS INC's FDA import refusal history?
SILVERHEALTH PRODUCTS INC (FEI: 2000006429) has 5 FDA import refusal record(s) in our database, spanning from 12/27/2005 to 1/11/2006.
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. SILVERHEALTH PRODUCTS INC's FEI number is 2000006429.
What types of violations has SILVERHEALTH PRODUCTS INC received?
SILVERHEALTH PRODUCTS INC 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 SILVERHEALTH PRODUCTS INC come from?
All FDA import refusal data for SILVERHEALTH PRODUCTS INC 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.