Bhinder Surgical Company
⚠️ High Risk
FEI: 1000134262 • Sialkot, Punjab • PAKISTAN
FEI Number
1000134262
Location
Sialkot, Punjab
Country
PAKISTANAddress
PO Box 1961, , Sialkot, Punjab, Pakistan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2011 | 87HRRSCISSORS | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 87HTXRONGEUR | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 87HXQCRIMPER, PIN | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 10/8/2010 | 76LYCBONE GRAFTING MATERIAL, SYNTHETIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/8/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/24/2010 | 87HTXRONGEUR | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 5/24/2010 | 87HRRSCISSORS | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 5/24/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 5/24/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 5/24/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 5/24/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 5/24/2010 | 87HTWBIT, DRILL | 290DE IMP GMP | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Bhinder Surgical Company's FDA import refusal history?
Bhinder Surgical Company (FEI: 1000134262) has 13 FDA import refusal record(s) in our database, spanning from 5/24/2010 to 10/28/2011.
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. Bhinder Surgical Company's FEI number is 1000134262.
What types of violations has Bhinder Surgical Company received?
Bhinder Surgical Company 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 Bhinder Surgical Company come from?
All FDA import refusal data for Bhinder Surgical Company 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.