HOLISTE LABORATOIRE ET DEVELOPME
⚠️ Moderate Risk
FEI: 3023321986 • Artaix • FRANCE
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 |
|---|---|---|---|
| 8/15/2022 | 64JAL01OXYGEN (MEDICINAL GAS) | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HOLISTE LABORATOIRE ET DEVELOPME's FDA import refusal history?
HOLISTE LABORATOIRE ET DEVELOPME (FEI: 3023321986) has 1 FDA import refusal record(s) in our database, spanning from 8/15/2022 to 8/15/2022.
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. HOLISTE LABORATOIRE ET DEVELOPME's FEI number is 3023321986.
What types of violations has HOLISTE LABORATOIRE ET DEVELOPME received?
HOLISTE LABORATOIRE ET DEVELOPME 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 HOLISTE LABORATOIRE ET DEVELOPME come from?
All FDA import refusal data for HOLISTE LABORATOIRE ET DEVELOPME 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.