Kerr Corporation
⚠️ High Risk
FEI: 2024312 • Orange, CA • UNITED STATES
FEI Number
2024312
Location
Orange, CA
Country
UNITED STATESAddress
1717 W Collins Ave, , Orange, CA, 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
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).
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.
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 |
|---|---|---|---|
| 10/24/2025 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | Division of Northeast Imports (DNEI) | |
| 10/24/2025 | 76EMACEMENT, DENTAL | Division of Northeast Imports (DNEI) | |
| 12/20/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 12/20/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 8/19/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/5/2024 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 76EMACEMENT, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/1/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 3/7/2022 | 76EMACEMENT, DENTAL | Division of Northeast Imports (DNEI) | |
| 2/12/2021 | 76EJLBUR, DENTAL | Division of Southeast Imports (DSEI) | |
| 2/12/2019 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 9/15/2017 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EMACEMENT, DENTAL | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EMACEMENT, DENTAL | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | Division of Northern Border Imports (DNBI) | |
| 1/11/2017 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New Orleans District Office (NOL-DO) | |
| 1/11/2017 | 76EMACEMENT, DENTAL | New Orleans District Office (NOL-DO) | |
| 1/11/2017 | 76EMACEMENT, DENTAL | New Orleans District Office (NOL-DO) | |
| 1/11/2017 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New Orleans District Office (NOL-DO) | |
| 1/5/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 11/18/2013 | 76NSMRESTORATION, RESIN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/3/2012 | 76KLEAGENT, TOOTH BONDING, RESIN | New York District Office (NYK-DO) | |
| 4/3/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 4/3/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 4/3/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 4/3/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 8/24/2011 | 76OIVDENTAL AMALGAM | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/7/2011 | 76KLEAGENT, TOOTH BONDING, RESIN | New York District Office (NYK-DO) | |
| 4/7/2011 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 2/23/2011 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/11/2011 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/11/2011 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2010 | 76EKMGUTTA-PERCHA | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/26/2010 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/18/2010 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/18/2010 | 76ELRPOST, ROOT CANAL | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/5/2007 | 76EJBHANDLE, INSTRUMENT, DENTAL | Seattle District Office (SEA-DO) | |
| 2/22/2007 | 76EMACEMENT, DENTAL | New York District Office (NYK-DO) | |
| 6/28/2006 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2006 | 76EMACEMENT, DENTAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Kerr Corporation's FDA import refusal history?
Kerr Corporation (FEI: 2024312) has 48 FDA import refusal record(s) in our database, spanning from 6/19/2006 to 10/24/2025.
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. Kerr Corporation's FEI number is 2024312.
What types of violations has Kerr Corporation received?
Kerr Corporation 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 Kerr Corporation come from?
All FDA import refusal data for Kerr Corporation 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.