3m Center
⚠️ Moderate Risk
FEI: 3003048814 • South St Paul, MN • UNITED STATES
FEI Number
3003048814
Location
South St Paul, MN
Country
UNITED STATESAddress
Bldg 275 3 E 02 Mn, , South St Paul, MN, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 4/17/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | New York District Office (NYK-DO) | |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 79FXXMASK, SURGICAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is 3m Center's FDA import refusal history?
3m Center (FEI: 3003048814) has 17 FDA import refusal record(s) in our database, spanning from 3/12/2009 to 4/17/2013.
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. 3m Center's FEI number is 3003048814.
What types of violations has 3m Center received?
3m Center has been cited for 2 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 3m Center come from?
All FDA import refusal data for 3m Center 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.