IsoTis OrthoBiologics, Inc.
⚠️ Moderate Risk
FEI: 3001503333 • Irvine, CA • UNITED STATES
FEI Number
3001503333
Location
Irvine, CA
Country
UNITED STATESAddress
2 Goodyear Ste A, , Irvine, CA, 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 |
|---|---|---|---|
| 11/27/2007 | 74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | Los Angeles District Office (LOS-DO) | |
| 11/27/2007 | 89NENFILLER RECOMB HUMAN BONE MORPHOGENETIC PROTEIN COLLAGEN SCAFFOLD W ALLOGRAFT BONE DOWEL, OSTEIONDUCT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/19/2003 | 76EMACEMENT, DENTAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is IsoTis OrthoBiologics, Inc.'s FDA import refusal history?
IsoTis OrthoBiologics, Inc. (FEI: 3001503333) has 3 FDA import refusal record(s) in our database, spanning from 5/19/2003 to 11/27/2007.
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. IsoTis OrthoBiologics, Inc.'s FEI number is 3001503333.
What types of violations has IsoTis OrthoBiologics, Inc. received?
IsoTis OrthoBiologics, Inc. 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 IsoTis OrthoBiologics, Inc. come from?
All FDA import refusal data for IsoTis OrthoBiologics, 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.