Examone
⚠️ Moderate Risk
FEI: 3009132884 • Shawnee Mission, KS • UNITED STATES
FEI Number
3009132884
Location
Shawnee Mission, KS
Country
UNITED STATESAddress
10101 Renner Blvd, , Shawnee Mission, KS, 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).
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 |
|---|---|---|---|
| 11/7/2011 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Florida District Office (FLA-DO) | |
| 11/7/2011 | 78EYNTRAY, IRRIGATION, STERILE | Florida District Office (FLA-DO) | |
| 11/7/2011 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Florida District Office (FLA-DO) | |
| 11/7/2011 | 75MPQSPECIMEN CONTAINER, URINE, DRUGS OF ABUSE, OVER THE COUNTER | Florida District Office (FLA-DO) | |
| 11/7/2011 | 78FHQHOLDER, NEEDLE | Florida District Office (FLA-DO) | |
| 11/7/2011 | 80MWVNEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING | Florida District Office (FLA-DO) | |
| 11/7/2011 | 79GEMGAUZE, ABSORBABLE | Florida District Office (FLA-DO) | |
| 11/7/2011 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | Florida District Office (FLA-DO) | |
| 11/7/2011 | 80KGXTAPE AND BANDAGE, ADHESIVE | Florida District Office (FLA-DO) | |
| 11/7/2011 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Examone's FDA import refusal history?
Examone (FEI: 3009132884) has 10 FDA import refusal record(s) in our database, spanning from 11/7/2011 to 11/7/2011.
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. Examone's FEI number is 3009132884.
What types of violations has Examone received?
Examone 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 Examone come from?
All FDA import refusal data for Examone 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.