Discount Optical
⚠️ Moderate Risk
FEI: 3009832858 • San Jose • COSTA RICA
FEI Number
3009832858
Location
San Jose
Country
COSTA RICAAddress
Pavas 150 Norte 150 Oeste Del Correo, , San Jose, , Costa Rica
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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2014 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | New Orleans District Office (NOL-DO) | |
| 4/2/2014 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | New Orleans District Office (NOL-DO) | |
| 7/5/2013 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Florida District Office (FLA-DO) | |
| 7/5/2013 | 86HQZFRAME, SPECTACLE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Discount Optical's FDA import refusal history?
Discount Optical (FEI: 3009832858) has 4 FDA import refusal record(s) in our database, spanning from 7/5/2013 to 12/17/2014.
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. Discount Optical's FEI number is 3009832858.
What types of violations has Discount Optical received?
Discount Optical has been cited for 3 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 Discount Optical come from?
All FDA import refusal data for Discount Optical 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.