Nyq Medical Group
⚠️ Moderate Risk
FEI: 3004210407 • Dalian • CHINA
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Nyq Medical Group's FDA import refusal history?
Nyq Medical Group (FEI: 3004210407) has 6 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 8/23/2004.
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. Nyq Medical Group's FEI number is 3004210407.
What types of violations has Nyq Medical Group received?
Nyq Medical Group 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 Nyq Medical Group come from?
All FDA import refusal data for Nyq Medical Group 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.