Aboca Spa
⚠️ High Risk
FEI: 3004095908 • Sansepolcro, Arezzo • ITALY
FEI Number
3004095908
Location
Sansepolcro, Arezzo
Country
ITALYAddress
Frazione Aboca 20, , Sansepolcro, Arezzo, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2025 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2015 | 54KCY08ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) | 260FALSE | Atlanta District Office (ATL-DO) |
| 12/6/2013 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Aboca Spa's FDA import refusal history?
Aboca Spa (FEI: 3004095908) has 3 FDA import refusal record(s) in our database, spanning from 12/6/2013 to 5/2/2025.
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. Aboca Spa's FEI number is 3004095908.
What types of violations has Aboca Spa received?
Aboca Spa has been cited for 2 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 Aboca Spa come from?
All FDA import refusal data for Aboca Spa 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.