PREMIUM DENTAL INSTRUMENTS
⚠️ Moderate Risk
FEI: 3027317132 • Sialkot • PAKISTAN
FEI Number
3027317132
Location
Sialkot
Country
PAKISTANAddress
Fatek Garh Road, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2023 | 76NXZKIT, DENTAL HYGIENE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PREMIUM DENTAL INSTRUMENTS's FDA import refusal history?
PREMIUM DENTAL INSTRUMENTS (FEI: 3027317132) has 1 FDA import refusal record(s) in our database, spanning from 6/16/2023 to 6/16/2023.
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. PREMIUM DENTAL INSTRUMENTS's FEI number is 3027317132.
What types of violations has PREMIUM DENTAL INSTRUMENTS received?
PREMIUM DENTAL INSTRUMENTS has been cited for 1 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 PREMIUM DENTAL INSTRUMENTS come from?
All FDA import refusal data for PREMIUM DENTAL INSTRUMENTS 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.