A.D.Surgico Private Limited
⚠️ Moderate Risk
FEI: 3003859540 • Sialkot-4 • PAKISTAN
FEI Number
3003859540
Location
Sialkot-4
Country
PAKISTANAddress
P.O.Box 270, , Sialkot-4, , 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 10/4/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 10/4/2005 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/3/2003 | 77JYASCISSORS, WIRE CUTTING, ENT | New York District Office (NYK-DO) |
Frequently Asked Questions
What is A.D.Surgico Private Limited's FDA import refusal history?
A.D.Surgico Private Limited (FEI: 3003859540) has 4 FDA import refusal record(s) in our database, spanning from 6/3/2003 to 10/4/2005.
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. A.D.Surgico Private Limited's FEI number is 3003859540.
What types of violations has A.D.Surgico Private Limited received?
A.D.Surgico Private Limited 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 A.D.Surgico Private Limited come from?
All FDA import refusal data for A.D.Surgico Private Limited 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.