PRECISET ENGINEERING LTD
⚠️ Moderate Risk
FEI: 3030084556 • Yas'Ur • ISRAEL
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
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 |
|---|---|---|---|
| 2/19/2025 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/19/2025 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/19/2025 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is PRECISET ENGINEERING LTD's FDA import refusal history?
PRECISET ENGINEERING LTD (FEI: 3030084556) has 3 FDA import refusal record(s) in our database, spanning from 2/19/2025 to 2/19/2025.
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. PRECISET ENGINEERING LTD's FEI number is 3030084556.
What types of violations has PRECISET ENGINEERING LTD received?
PRECISET ENGINEERING LTD 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 PRECISET ENGINEERING LTD come from?
All FDA import refusal data for PRECISET ENGINEERING 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.