Otto Bock Health Care
⚠️ Moderate Risk
FEI: 1000228440 • Burlington, Ontario • CANADA
FEI Number
1000228440
Location
Burlington, Ontario
Country
CANADAAddress
5470 Harvester Rd, , Burlington, Ontario, Canada
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 1/4/2011 | 87KXEPROSTHESIS, WRIST, HEMI-, ULNAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2011 | 87MQOPROSTHESTIC DISC NUCLEUS DEVICE | New Orleans District Office (NOL-DO) | |
| 2/24/2004 | 87LBCPROSTHESIS, FINGER, CONSTRAINED, METAL, CEMENTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Otto Bock Health Care's FDA import refusal history?
Otto Bock Health Care (FEI: 1000228440) has 3 FDA import refusal record(s) in our database, spanning from 2/24/2004 to 1/4/2011.
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. Otto Bock Health Care's FEI number is 1000228440.
What types of violations has Otto Bock Health Care received?
Otto Bock Health Care 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 Otto Bock Health Care come from?
All FDA import refusal data for Otto Bock Health Care 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.