Quality Concept (Pvt) Ltd.
⚠️ Moderate Risk
FEI: 3002090132 • Sialkot • PAKISTAN
FEI Number
3002090132
Location
Sialkot
Country
PAKISTANAddress
15-a-01 Small, , 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2010 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Minneapolis District Office (MIN-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) |
| 7/1/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 6/1/2010 | 85HFXCLAMP, CIRCUMCISION | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 5/19/2010 | 79GDFGUIDE, NEEDLE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 3/29/2010 | 86HNFSCISSORS, OPHTHALMIC | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Quality Concept (Pvt) Ltd.'s FDA import refusal history?
Quality Concept (Pvt) Ltd. (FEI: 3002090132) has 7 FDA import refusal record(s) in our database, spanning from 3/29/2010 to 12/8/2010.
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 Concept (Pvt) Ltd.'s FEI number is 3002090132.
What types of violations has Quality Concept (Pvt) Ltd. received?
Quality Concept (Pvt) Ltd. 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 Concept (Pvt) Ltd. come from?
All FDA import refusal data for Quality Concept (Pvt) Ltd. 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.