Everlast Surgical Company
⚠️ Moderate Risk
FEI: 3003145254 • Sialkot • PAKISTAN
FEI Number
3003145254
Location
Sialkot
Country
PAKISTANAddress
P.O. Box #460, 460 Roras Road, Sialkot, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2011 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/22/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 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) |
| 6/21/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/20/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/17/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/8/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/2/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/2/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/2/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/31/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/31/2011 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Everlast Surgical Company's FDA import refusal history?
Everlast Surgical Company (FEI: 3003145254) has 40 FDA import refusal record(s) in our database, spanning from 5/31/2011 to 8/12/2011.
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. Everlast Surgical Company's FEI number is 3003145254.
What types of violations has Everlast Surgical Company received?
Everlast Surgical Company 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 Everlast Surgical Company come from?
All FDA import refusal data for Everlast 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.