AAKK SURGICAL CORPORATION
⚠️ High Risk
FEI: 3007817017 • Sialkot, Punjab • PAKISTAN
FEI Number
3007817017
Location
Sialkot, Punjab
Country
PAKISTANAddress
KHAN MAHAL ROAD, KAMELA, , 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).
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 |
|---|---|---|---|
| 7/30/2013 | 73CCWLARYNGOSCOPE, RIGID | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCEANALYZER, GAS, OXYGEN, PARTIAL PRESSURE, BLOOD-PHASE, INDWELLING | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 80FNSRING CUTTER | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 80FNSRING CUTTER | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 80FNSRING CUTTER | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73BWBFORCEPS, TUBE INTRODUCTION | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73BWBFORCEPS, TUBE INTRODUCTION | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73BWBFORCEPS, TUBE INTRODUCTION | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CALLARYNGOSCOPE, NON-RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 9/17/2010 | 73CCWLARYNGOSCOPE, RIGID | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AAKK SURGICAL CORPORATION's FDA import refusal history?
AAKK SURGICAL CORPORATION (FEI: 3007817017) has 40 FDA import refusal record(s) in our database, spanning from 9/17/2010 to 7/30/2013.
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. AAKK SURGICAL CORPORATION's FEI number is 3007817017.
What types of violations has AAKK SURGICAL CORPORATION received?
AAKK SURGICAL CORPORATION 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 AAKK SURGICAL CORPORATION come from?
All FDA import refusal data for AAKK SURGICAL CORPORATION 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.