Ethicon Endo-Surgery Inc
⚠️ Moderate Risk
FEI: 1527736 • Blue Ash, OH • UNITED STATES
FEI Number
1527736
Location
Blue Ash, OH
Country
UNITED STATESAddress
4545 Creek Rd, , Blue Ash, OH, 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
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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 |
|---|---|---|---|
| 4/12/2019 | 79GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | Division of Northern Border Imports (DNBI) | |
| 4/12/2019 | 79GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | Division of Northern Border Imports (DNBI) | |
| 4/12/2019 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of Northern Border Imports (DNBI) | |
| 4/12/2019 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of Northern Border Imports (DNBI) | |
| 4/12/2019 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of Northern Border Imports (DNBI) | |
| 4/12/2019 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of Northern Border Imports (DNBI) | |
| 4/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 4/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 4/8/2019 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 4/8/2019 | 79GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 79GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | Division of Southeast Imports (DSEI) | |
| 2/15/2019 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 10/27/2015 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 2/10/2002 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ethicon Endo-Surgery Inc's FDA import refusal history?
Ethicon Endo-Surgery Inc (FEI: 1527736) has 29 FDA import refusal record(s) in our database, spanning from 2/10/2002 to 4/12/2019.
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 Endo-Surgery Inc's FEI number is 1527736.
What types of violations has Ethicon Endo-Surgery Inc received?
Ethicon Endo-Surgery Inc 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 Ethicon Endo-Surgery Inc come from?
All FDA import refusal data for Ethicon Endo-Surgery 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.