Nawaz Surgical Co.
⚠️ Moderate Risk
FEI: 3006353396 • Sialkot • PAKISTAN
FEI Number
3006353396
Location
Sialkot
Country
PAKISTANAddress
Jammu Road, Near Rajput Foundry, Sialkot, , Pakistan
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
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2010 | 79HTCPLIERS, SURGICAL | 477HOLES | New York District Office (NYK-DO) |
| 8/11/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 90IZTCONE, RADIOGRAPHIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79HXDCLAMP | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79HRQHEMOSTAT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nawaz Surgical Co.'s FDA import refusal history?
Nawaz Surgical Co. (FEI: 3006353396) has 7 FDA import refusal record(s) in our database, spanning from 8/11/2010 to 10/15/2010.
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. Nawaz Surgical Co.'s FEI number is 3006353396.
What types of violations has Nawaz Surgical Co. received?
Nawaz Surgical Co. 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 Nawaz Surgical Co. come from?
All FDA import refusal data for Nawaz Surgical Co. 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.