Dr. Sirj Surgical
⚠️ Moderate Risk
FEI: 3005135347 • Sialkot, Punjab • PAKISTAN
FEI Number
3005135347
Location
Sialkot, Punjab
Country
PAKISTANAddress
New Abadi New Mubaric Pura, , Sialkot, Punjab, 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.
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 |
|---|---|---|---|
| 1/24/2008 | 79FSMTRAY, SURGICAL, INSTRUMENT | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 1/24/2008 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 1/24/2008 | 79HTDFORCEPS | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 4/27/2006 | 79HTCPLIERS, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 4/27/2006 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/6/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/6/2006 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr. Sirj Surgical's FDA import refusal history?
Dr. Sirj Surgical (FEI: 3005135347) has 7 FDA import refusal record(s) in our database, spanning from 3/6/2006 to 1/24/2008.
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. Dr. Sirj Surgical's FEI number is 3005135347.
What types of violations has Dr. Sirj Surgical received?
Dr. Sirj Surgical has been cited for 2 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 Dr. Sirj Surgical come from?
All FDA import refusal data for Dr. Sirj Surgical 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.