BLANCHARD VISION CORP.
⚠️ Moderate Risk
FEI: 3002807465 • Sherbrooke, Quebec • CANADA
FEI Number
3002807465
Location
Sherbrooke, Quebec
Country
CANADAAddress
1552 King St W Suite 200, 1552 RUE KING OUEST, SUITE 200, Sherbrooke, Quebec, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2024 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 10/30/2001 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 10/30/2001 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 10/30/2001 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is BLANCHARD VISION CORP.'s FDA import refusal history?
BLANCHARD VISION CORP. (FEI: 3002807465) has 4 FDA import refusal record(s) in our database, spanning from 10/30/2001 to 11/29/2024.
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. BLANCHARD VISION CORP.'s FEI number is 3002807465.
What types of violations has BLANCHARD VISION CORP. received?
BLANCHARD VISION CORP. has been cited for 5 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 BLANCHARD VISION CORP. come from?
All FDA import refusal data for BLANCHARD VISION 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.