Quality Point International
⚠️ High Risk
FEI: 3003745141 • Sialkot • 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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2011 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/14/2010 | 79LRPTRAY, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/14/2010 | 79LRPTRAY, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/7/2010 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/7/2010 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/28/2010 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/3/2010 | 79FZTCUTTER, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 8/26/2010 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Baltimore District Office (BLT-DO) |
| 8/26/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Baltimore District Office (BLT-DO) |
| 8/26/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Baltimore District Office (BLT-DO) |
| 7/7/2010 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 7/7/2010 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 6/25/2010 | 79FZTCUTTER, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 6/1/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 3/17/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/19/2010 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Quality Point International's FDA import refusal history?
Quality Point International (FEI: 3003745141) has 22 FDA import refusal record(s) in our database, spanning from 2/19/2010 to 1/31/2011.
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. Quality Point International's FEI number is 3003745141.
What types of violations has Quality Point International received?
Quality Point International 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 Quality Point International come from?
All FDA import refusal data for Quality Point 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.