CENTRO INTEGRAL OPTICO, SA DE CV
⚠️ Moderate Risk
FEI: 3007648376 • EDO • MEXICO
FEI Number
3007648376
Location
EDO
Country
MEXICOAddress
GENERAL AGUSTIN MILLAN 42, COL. ALCE BLANCO NAUCALPAN, EDO, , Mexico
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2011 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 8/19/2009 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | New Orleans District Office (NOL-DO) | |
| 8/19/2009 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/5/2009 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CENTRO INTEGRAL OPTICO, SA DE CV's FDA import refusal history?
CENTRO INTEGRAL OPTICO, SA DE CV (FEI: 3007648376) has 4 FDA import refusal record(s) in our database, spanning from 2/5/2009 to 1/5/2011.
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. CENTRO INTEGRAL OPTICO, SA DE CV's FEI number is 3007648376.
What types of violations has CENTRO INTEGRAL OPTICO, SA DE CV received?
CENTRO INTEGRAL OPTICO, SA DE CV 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 CENTRO INTEGRAL OPTICO, SA DE CV come from?
All FDA import refusal data for CENTRO INTEGRAL OPTICO, SA DE CV 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.