BIOSURGERY R&D ETHICON INC
⚠️ High Risk
FEI: 3020507463 • Bridgewater, NJ • UNITED STATES
FEI Number
3020507463
Location
Bridgewater, NJ
Country
UNITED STATESAddress
737 Us Highway 22, , Bridgewater, NJ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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 |
|---|---|---|---|
| 3/9/2023 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BIOSURGERY R&D ETHICON INC's FDA import refusal history?
BIOSURGERY R&D ETHICON INC (FEI: 3020507463) has 23 FDA import refusal record(s) in our database, spanning from 3/9/2023 to 3/9/2023.
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. BIOSURGERY R&D ETHICON INC's FEI number is 3020507463.
What types of violations has BIOSURGERY R&D ETHICON INC received?
BIOSURGERY R&D ETHICON INC 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 BIOSURGERY R&D ETHICON INC come from?
All FDA import refusal data for BIOSURGERY R&D 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.