ConvaTec, Inc
⚠️ Moderate Risk
FEI: 3011987967 • Greensboro, NC • UNITED STATES
FEI Number
3011987967
Location
Greensboro, NC
Country
UNITED STATESAddress
7815 National Service Rd Ste 600, , Greensboro, NC, 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).
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.
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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 |
|---|---|---|---|
| 3/6/2014 | 78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY | New England District Office (NWE-DO) | |
| 9/4/2013 | 80NZIDRESSING, WOUND, DRUG | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 80NZIDRESSING, WOUND, DRUG | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 79NADDRESSING, WOUND, OCCLUSIVE | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 80NZIDRESSING, WOUND, DRUG | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 80NZIDRESSING, WOUND, DRUG | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 80NZIDRESSING, WOUND, DRUG | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 80NZIDRESSING, WOUND, DRUG | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 79NADDRESSING, WOUND, OCCLUSIVE | Atlanta District Office (ATL-DO) | |
| 9/4/2013 | 79NADDRESSING, WOUND, OCCLUSIVE | Atlanta District Office (ATL-DO) | |
| 12/9/2008 | 80NZIDRESSING, WOUND, DRUG | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 12/9/2008 | 80FQMBANDAGE, ELASTIC | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 5/25/2004 | 79MGPDRESSING, WOUND AND BURN, OCCLUSIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/25/2004 | 78EZRCEMENT, STOMAL APPLIANCE, OSTOMY | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ConvaTec, Inc's FDA import refusal history?
ConvaTec, Inc (FEI: 3011987967) has 14 FDA import refusal record(s) in our database, spanning from 5/25/2004 to 3/6/2014.
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. ConvaTec, Inc's FEI number is 3011987967.
What types of violations has ConvaTec, Inc received?
ConvaTec, Inc has been cited for 5 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 ConvaTec, Inc come from?
All FDA import refusal data for ConvaTec, Inc 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.