Innovint Aircraft Interior
⚠️ Moderate Risk
FEI: 3001058874 • Hamburg, Hamburg • GERMANY
FEI Number
3001058874
Location
Hamburg, Hamburg
Country
GERMANYAddress
Holzmuhlenstr. 84-86, , Hamburg, Hamburg, Germany
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 3/27/2023 | 79OHOFIRST AID KIT WITHOUT DRUG | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/9/2016 | 89IORWHEELCHAIR, MECHANICAL | Division of Southeast Imports (DSEI) | |
| 2/3/2016 | 80OKIEMERGENCY RESPONSE SAFETY KIT | Chicago District Office (CHI-DO) | |
| 12/4/2014 | 79LRRKIT, FIRST AID | New York District Office (NYK-DO) | |
| 1/23/2013 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | New Orleans District Office (NOL-DO) | |
| 12/18/2012 | 79LRRKIT, FIRST AID | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Innovint Aircraft Interior's FDA import refusal history?
Innovint Aircraft Interior (FEI: 3001058874) has 6 FDA import refusal record(s) in our database, spanning from 12/18/2012 to 3/27/2023.
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. Innovint Aircraft Interior's FEI number is 3001058874.
What types of violations has Innovint Aircraft Interior received?
Innovint Aircraft Interior 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 Innovint Aircraft Interior come from?
All FDA import refusal data for Innovint Aircraft Interior 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.