Falcon Surgical Co. (Pvt.) Ltd.
⚠️ Moderate Risk
FEI: 3004216008 • Sialkot, Punjab • PAKISTAN
FEI Number
3004216008
Location
Sialkot, Punjab
Country
PAKISTANAddress
HO. Falcon House, Village Golophala, Near Ugoki Town, Wazirabad Road, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2014 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/11/2014 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/11/2014 | 79HTDFORCEPS | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/11/2014 | 76EFLFORCEPS, DRESSING, DENTAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/11/2014 | 76EIGRETRACTOR, ALL TYPES | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/9/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/9/2013 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/16/2010 | 79DWHBLADE, SAW, SURGICAL, CARDIOVASCULAR | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/29/2007 | 76JEPRETAINER, MATRIX | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/29/2007 | 76EKICARRIER, AMALGAM, OPERATIVE | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/29/2007 | 76JEXPLIER, ORTHODONTIC | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/29/2007 | 76EIGRETRACTOR, ALL TYPES | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 11/2/2005 | 79HXMRETRACTOR | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 11/2/2005 | 79HXMRETRACTOR | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 11/2/2005 | 79HTDFORCEPS | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 11/2/2005 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Falcon Surgical Co. (Pvt.) Ltd.'s FDA import refusal history?
Falcon Surgical Co. (Pvt.) Ltd. (FEI: 3004216008) has 16 FDA import refusal record(s) in our database, spanning from 11/2/2005 to 8/11/2014.
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. Falcon Surgical Co. (Pvt.) Ltd.'s FEI number is 3004216008.
What types of violations has Falcon Surgical Co. (Pvt.) Ltd. received?
Falcon Surgical Co. (Pvt.) Ltd. 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 Falcon Surgical Co. (Pvt.) Ltd. come from?
All FDA import refusal data for Falcon Surgical Co. (Pvt.) Ltd. 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.