Wise Instruments Manufacturing Co.
⚠️ Moderate Risk
FEI: 3003882399 • Sialkot, Punjab • PAKISTAN
FEI Number
3003882399
Location
Sialkot, Punjab
Country
PAKISTANAddress
Airport Road, Mughal Pura, , 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
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.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2005 | 76EMKCURETTE, SURGICAL, DENTAL | 479DV QUALITY | New York District Office (NYK-DO) |
| 12/13/2005 | 78FHONEEDLE, PNEUMOPERITONEUM, SPRING LOADED | 479DV QUALITY | New York District Office (NYK-DO) |
| 12/13/2005 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | 479DV QUALITY | New York District Office (NYK-DO) |
| 10/7/2005 | 76EMJELEVATOR, SURGICAL, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 4/27/2005 | 76JEXPLIER, ORTHODONTIC | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wise Instruments Manufacturing Co.'s FDA import refusal history?
Wise Instruments Manufacturing Co. (FEI: 3003882399) has 5 FDA import refusal record(s) in our database, spanning from 4/27/2005 to 12/13/2005.
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. Wise Instruments Manufacturing Co.'s FEI number is 3003882399.
What types of violations has Wise Instruments Manufacturing Co. received?
Wise Instruments Manufacturing Co. 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 Wise Instruments Manufacturing Co. come from?
All FDA import refusal data for Wise Instruments Manufacturing Co. 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.