Atlantic Enterprises
⚠️ Moderate Risk
FEI: 3002806307 • Sialkot, Punjab • PAKISTAN
FEI Number
3002806307
Location
Sialkot, Punjab
Country
PAKISTANAddress
Kulluwall Road, Gohad Pur, Airport 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.
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).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2024 | 85HHKCURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/1/2016 | 76EJGFORCEPS, RUBBER DAM CLAMP | 484DV NAME | New York District Office (NYK-DO) |
| 6/1/2016 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | New York District Office (NYK-DO) | |
| 1/31/2012 | 76EJYPLIERS, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/31/2012 | 87HRRSCISSORS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/31/2012 | 79FXESPECULUM, NON-ILLUMINATED | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Atlantic Enterprises's FDA import refusal history?
Atlantic Enterprises (FEI: 3002806307) has 6 FDA import refusal record(s) in our database, spanning from 1/31/2012 to 7/31/2024.
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. Atlantic Enterprises's FEI number is 3002806307.
What types of violations has Atlantic Enterprises received?
Atlantic Enterprises 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 Atlantic Enterprises come from?
All FDA import refusal data for Atlantic Enterprises 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.