Ethicon, Inc.
⚠️ Moderate Risk
FEI: 2210968 • Somerville, NJ • UNITED STATES
FEI Number
2210968
Location
Somerville, NJ
Country
UNITED STATESAddress
1000 Us Highway 22, , Somerville, NJ, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2021 | 79GAPSUTURE, NONABSORBABLE, SILK | Division of Northern Border Imports (DNBI) | |
| 2/19/2021 | 79LMGAGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED | Division of Northern Border Imports (DNBI) | |
| 9/19/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 5/26/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/4/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 4/25/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Seattle District Office (SEA-DO) | |
| 3/30/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 3/30/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 3/7/2013 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 3741FRNMFGREG | New York District Office (NYK-DO) |
| 10/17/2009 | 79GAOSUTURE, NONABSORBABLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2007 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/21/2005 | 85HIHHYSTEROSCOPE (AND ACCESSORIES) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/7/2001 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ethicon, Inc.'s FDA import refusal history?
Ethicon, Inc. (FEI: 2210968) has 24 FDA import refusal record(s) in our database, spanning from 12/7/2001 to 2/19/2021.
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. Ethicon, Inc.'s FEI number is 2210968.
What types of violations has Ethicon, Inc. received?
Ethicon, 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 Ethicon, Inc. come from?
All FDA import refusal data for Ethicon, 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.