CVI Melles Griot
⚠️ Moderate Risk
FEI: 2024018 • Carlsbad, CA • UNITED STATES
FEI Number
2024018
Location
Carlsbad, CA
Country
UNITED STATESAddress
2051 Palomar Airport Rd, , Carlsbad, CA, United States
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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 |
|---|---|---|---|
| 2/15/2005 | 53QC99COSMETIC PACKAGING AND LABELING, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/21/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 3/18/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is CVI Melles Griot's FDA import refusal history?
CVI Melles Griot (FEI: 2024018) has 3 FDA import refusal record(s) in our database, spanning from 3/18/2002 to 2/15/2005.
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. CVI Melles Griot's FEI number is 2024018.
What types of violations has CVI Melles Griot received?
CVI Melles Griot 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 CVI Melles Griot come from?
All FDA import refusal data for CVI Melles Griot 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.