Technicality Inc.
⚠️ High Risk
FEI: 1450901 • Addison, IL • UNITED STATES
FEI Number
1450901
Location
Addison, IL
Country
UNITED STATESAddress
661 S Addison Rd, , Addison, IL, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2012 | 87HRRSCISSORS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/10/2012 | 79HTDFORCEPS | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 1/10/2012 | 87HRRSCISSORS | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 1/6/2012 | 87HRRSCISSORS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79HTDFORCEPS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79HTDFORCEPS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 87HRRSCISSORS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 87HRRSCISSORS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79HTDFORCEPS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 79HTDFORCEPS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Technicality Inc.'s FDA import refusal history?
Technicality Inc. (FEI: 1450901) has 11 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 2/23/2012.
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. Technicality Inc.'s FEI number is 1450901.
What types of violations has Technicality Inc. received?
Technicality Inc. has been cited for 1 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 Technicality Inc. come from?
All FDA import refusal data for Technicality 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.