Medical International Orthopedic
⚠️ Moderate Risk
FEI: 3005812088 • New Delhi, Delhi • INDIA
FEI Number
3005812088
Location
New Delhi, Delhi
Country
INDIAAddress
A - 3 Jawahar, 8b/U, New Delhi, Delhi, India
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).
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 |
|---|---|---|---|
| 4/23/2012 | 87LRNWIRE, SURGICAL | New York District Office (NYK-DO) | |
| 4/23/2012 | 87HWCSCREW, FIXATION, BONE | New York District Office (NYK-DO) | |
| 4/23/2012 | 87HRSPLATE, FIXATION, BONE | New York District Office (NYK-DO) | |
| 4/23/2012 | 87HTNWASHER, BOLT, NUT | New York District Office (NYK-DO) | |
| 4/23/2012 | 87JDSNAIL, FIXATION, BONE | New York District Office (NYK-DO) | |
| 4/23/2012 | 87OQIHIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEMENTED | New York District Office (NYK-DO) | |
| 9/29/2006 | 79FZYHAMMER, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2006 | 79GFJMALLET, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2006 | 79FZYHAMMER, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2006 | 79FZSCURETTE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/29/2006 | 79HWMOSTEOTOME | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Medical International Orthopedic's FDA import refusal history?
Medical International Orthopedic (FEI: 3005812088) has 11 FDA import refusal record(s) in our database, spanning from 9/29/2006 to 4/23/2012.
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. Medical International Orthopedic's FEI number is 3005812088.
What types of violations has Medical International Orthopedic received?
Medical International Orthopedic 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 Medical International Orthopedic come from?
All FDA import refusal data for Medical International Orthopedic 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.