Lead Dental Instruments Co.
⚠️ Moderate Risk
FEI: 3012117860 • Sialkot, Punjab • PAKISTAN
FEI Number
3012117860
Location
Sialkot, Punjab
Country
PAKISTANAddress
Vill.Rahim Pur, Po Ugoki, Wazirabad Road, 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
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 |
|---|---|---|---|
| 2/18/2016 | 76EJBHANDLE, INSTRUMENT, DENTAL | 290DE IMP GMP | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Lead Dental Instruments Co.'s FDA import refusal history?
Lead Dental Instruments Co. (FEI: 3012117860) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2016 to 2/18/2016.
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. Lead Dental Instruments Co.'s FEI number is 3012117860.
What types of violations has Lead Dental Instruments Co. received?
Lead Dental Instruments Co. 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 Lead Dental Instruments Co. come from?
All FDA import refusal data for Lead Dental Instruments 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.