Washington Surgical International
🚨 Critical Risk
FEI: 3004598675 • Sialkot, Punjab • PAKISTAN
FEI Number
3004598675
Location
Sialkot, Punjab
Country
PAKISTANAddress
Roras Rd, Opposite Gohar Bldg Material, , Sialkot, Punjab, Pakistan
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2025 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 12/12/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southwest Imports (DSWI) | |
| 12/5/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Division of Southwest Imports (DSWI) | |
| 12/5/2025 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southwest Imports (DSWI) | |
| 12/3/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 12/3/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Northeast Imports (DNEI) | |
| 11/17/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southwest Imports (DSWI) | |
| 11/12/2025 | 80MEDSTERILANT, MEDICAL DEVICES | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/6/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 11/6/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 11/5/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 11/5/2025 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 11/5/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 11/5/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 11/5/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 10/1/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 10/1/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 10/1/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 85HHMSOUND, UTERINE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/30/2025 | 78FHQHOLDER, NEEDLE | 47NON STD | Division of Southwest Imports (DSWI) |
| 9/2/2025 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Division of Northeast Imports (DNEI) | |
| 9/2/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Northeast Imports (DNEI) | |
| 9/2/2025 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 288STD LABEL | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Washington Surgical International's FDA import refusal history?
Washington Surgical International (FEI: 3004598675) has 59 FDA import refusal record(s) in our database, spanning from 9/2/2025 to 12/17/2025.
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. Washington Surgical International's FEI number is 3004598675.
What types of violations has Washington Surgical International received?
Washington Surgical International has been cited for 5 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 Washington Surgical International come from?
All FDA import refusal data for Washington Surgical International 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.