Kerr Corporation
⚠️ Moderate Risk
FEI: 1815757 • Romulus, MI • UNITED STATES
FEI Number
1815757
Location
Romulus, MI
Country
UNITED STATESAddress
28200 Wick Rd, , Romulus, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2017 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EMACEMENT, DENTAL | Division of Northern Border Imports (DNBI) | |
| 2/15/2013 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | 341REGISTERED | Detroit District Office (DET-DO) |
| 10/25/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Los Angeles District Office (LOS-DO) | |
| 10/25/2012 | 76EMACEMENT, DENTAL | Los Angeles District Office (LOS-DO) | |
| 10/25/2012 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | Los Angeles District Office (LOS-DO) | |
| 10/25/2012 | 76KLEAGENT, TOOTH BONDING, RESIN | Los Angeles District Office (LOS-DO) | |
| 10/25/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Los Angeles District Office (LOS-DO) | |
| 10/25/2012 | 76KLEAGENT, TOOTH BONDING, RESIN | Los Angeles District Office (LOS-DO) | |
| 10/25/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Los Angeles District Office (LOS-DO) | |
| 5/9/2012 | 76EMRFILE, PERIODONTIC | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/7/2011 | 76EFHPAPER, ARTICULATION | New York District Office (NYK-DO) | |
| 1/11/2011 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/11/2011 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/11/2011 | 76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2010 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kerr Corporation's FDA import refusal history?
Kerr Corporation (FEI: 1815757) has 17 FDA import refusal record(s) in our database, spanning from 9/23/2010 to 9/15/2017.
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 1815757.
What types of violations has Kerr Corporation received?
Kerr Corporation 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 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.