S.R. Innovative Products Inc.
⚠️ High Risk
FEI: 3008257305 • Anjou, QUEBEC • CANADA
FEI Number
3008257305
Location
Anjou, QUEBEC
Country
CANADAAddress
8363 Crois Montrichard, , Anjou, QUEBEC, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 6/11/2010 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/11/2010 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/11/2010 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/11/2010 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/11/2010 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/11/2010 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/11/2010 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is S.R. Innovative Products Inc.'s FDA import refusal history?
S.R. Innovative Products Inc. (FEI: 3008257305) has 7 FDA import refusal record(s) in our database, spanning from 6/11/2010 to 6/11/2010.
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. S.R. Innovative Products Inc.'s FEI number is 3008257305.
What types of violations has S.R. Innovative Products Inc. received?
S.R. Innovative 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 S.R. Innovative Products Inc. come from?
All FDA import refusal data for S.R. Innovative 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.