Unique Instruments, Inc.
⚠️ Moderate Risk
FEI: 1828288 • Bridgeport, MI • UNITED STATES
FEI Number
1828288
Location
Bridgeport, MI
Country
UNITED STATESAddress
6688 Dixie Hwy, , Bridgeport, MI, 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
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2016 | 87MOOORTHOPEDIC IMPLANT MATERIAL | New York District Office (NYK-DO) | |
| 2/14/2014 | 76ECIBAND, ELASTIC, ORTHODONTIC | New Orleans District Office (NOL-DO) | |
| 1/7/2012 | 79GFGBIT, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Unique Instruments, Inc.'s FDA import refusal history?
Unique Instruments, Inc. (FEI: 1828288) has 3 FDA import refusal record(s) in our database, spanning from 1/7/2012 to 2/4/2016.
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. Unique Instruments, Inc.'s FEI number is 1828288.
What types of violations has Unique Instruments, Inc. received?
Unique Instruments, Inc. has been cited for 4 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 Unique Instruments, Inc. come from?
All FDA import refusal data for Unique Instruments, Inc. 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.