Gianluca Mech S.P.A.
⚠️ Moderate Risk
FEI: 3009410247 • Asigliano Veneto, Vicenza • ITALY
FEI Number
3009410247
Location
Asigliano Veneto, Vicenza
Country
ITALYAddress
Via Rodolfo Mech 80, , Asigliano Veneto, Vicenza, Italy
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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2021 | 54FCY12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 83NO PROCESS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Gianluca Mech S.P.A.'s FDA import refusal history?
Gianluca Mech S.P.A. (FEI: 3009410247) has 1 FDA import refusal record(s) in our database, spanning from 8/6/2021 to 8/6/2021.
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. Gianluca Mech S.P.A.'s FEI number is 3009410247.
What types of violations has Gianluca Mech S.P.A. received?
Gianluca Mech S.P.A. 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 Gianluca Mech S.P.A. come from?
All FDA import refusal data for Gianluca Mech S.P.A. 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.