Raj Surgical Works
⚠️ Moderate Risk
FEI: 3006897696 • Usmanpur • INDIA
FEI Number
3006897696
Location
Usmanpur
Country
INDIAAddress
D-128/A, Street No. 11 Azad Gali, , Usmanpur, , 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 |
|---|---|---|---|
| 11/23/2011 | 87MOOORTHOPEDIC IMPLANT MATERIAL | Division of Southeast Imports (DSEI) | |
| 10/3/2011 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 9/28/2011 | 87MOOORTHOPEDIC IMPLANT MATERIAL | Florida District Office (FLA-DO) | |
| 9/28/2011 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/14/2011 | 87MOOORTHOPEDIC IMPLANT MATERIAL | Division of Southeast Imports (DSEI) | |
| 9/15/2010 | 87MOOORTHOPEDIC IMPLANT MATERIAL | Division of Southeast Imports (DSEI) | |
| 7/15/2009 | 87MOOORTHOPEDIC IMPLANT MATERIAL | Division of Southeast Imports (DSEI) | |
| 6/23/2008 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Raj Surgical Works's FDA import refusal history?
Raj Surgical Works (FEI: 3006897696) has 8 FDA import refusal record(s) in our database, spanning from 6/23/2008 to 11/23/2011.
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. Raj Surgical Works's FEI number is 3006897696.
What types of violations has Raj Surgical Works received?
Raj Surgical Works 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 Raj Surgical Works come from?
All FDA import refusal data for Raj Surgical Works 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.