DENTSCON
⚠️ Moderate Risk
FEI: 3012694410 • Sialkot • PAKISTAN
FEI Number
3012694410
Location
Sialkot
Country
PAKISTANAddress
College Road Daska, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2024 | 88IDZCASSETTES, TISSUE | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 1/3/2024 | 76EMNSCALER, PERIODONTIC | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 1/3/2024 | 80NNICONTAINER, SPECIMEN, NON-STERILE | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 1/3/2024 | 76EMNSCALER, PERIODONTIC | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is DENTSCON's FDA import refusal history?
DENTSCON (FEI: 3012694410) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2024 to 1/3/2024.
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. DENTSCON's FEI number is 3012694410.
What types of violations has DENTSCON received?
DENTSCON 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 DENTSCON come from?
All FDA import refusal data for DENTSCON 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.