Buraq Surgical Corp.
⚠️ Moderate Risk
FEI: 3002806612 • Sialkot-4 • PAKISTAN
FEI Number
3002806612
Location
Sialkot-4
Country
PAKISTANAddress
59-C Small Industrial Estate, , 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
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 |
|---|---|---|---|
| 7/30/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/24/2011 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HRQHEMOSTAT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79GDZHANDLE, SCALPEL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 84HAXTONG, SKULL FOR TRACTION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Buraq Surgical Corp.'s FDA import refusal history?
Buraq Surgical Corp. (FEI: 3002806612) has 34 FDA import refusal record(s) in our database, spanning from 6/21/2011 to 7/30/2012.
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. Buraq Surgical Corp.'s FEI number is 3002806612.
What types of violations has Buraq Surgical Corp. received?
Buraq Surgical Corp. has been cited for 1 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 Buraq Surgical Corp. come from?
All FDA import refusal data for Buraq Surgical Corp. 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.