Nabi Surgico
⚠️ Moderate Risk
FEI: 3004761843 • Sialkot • PAKISTAN
FEI Number
3004761843
Location
Sialkot
Country
PAKISTANAddress
Khadim Ali Road, , 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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2005 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/24/2005 | 76EIGRETRACTOR, ALL TYPES | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/24/2005 | 79HXDCLAMP | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/16/2004 | 80LDQDEVICE, GENERAL MEDICAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Nabi Surgico's FDA import refusal history?
Nabi Surgico (FEI: 3004761843) has 4 FDA import refusal record(s) in our database, spanning from 12/16/2004 to 1/24/2005.
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. Nabi Surgico's FEI number is 3004761843.
What types of violations has Nabi Surgico received?
Nabi Surgico 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 Nabi Surgico come from?
All FDA import refusal data for Nabi Surgico 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.