Angelini Francesco Acraf Spa
⚠️ Moderate Risk
FEI: 1000399573 • Rome, Rome • ITALY
FEI Number
1000399573
Location
Rome, Rome
Country
ITALYAddress
Viale Amelia 70, , Rome, Rome, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 6/8/2017 | 62YBH03SUPROFEN (ANTI-INFLAMMATORY, PART II) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 6/8/2017 | 62YBH03SUPROFEN (ANTI-INFLAMMATORY, PART II) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 6/8/2017 | 62YBH03SUPROFEN (ANTI-INFLAMMATORY, PART II) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 6/8/2017 | 60LBA13CALCIUM CARBASPIRIN (ANALGESIC) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 6/8/2017 | 62GIA41IBUPROFEN (ANTI-INFLAMMATORY) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 5/24/2017 | 62UBE99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 62UBE99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 62UBE99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/25/2015 | 60LAY01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 11/14/2011 | 55QY58GLYCERIN (PHARMACEUTIC NECESSITY - SOLVENT) | New Orleans District Office (NOL-DO) | |
| 9/9/2011 | 54HBA04FISH OIL (FATS AND LIPID SUBSTANCES) | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Angelini Francesco Acraf Spa's FDA import refusal history?
Angelini Francesco Acraf Spa (FEI: 1000399573) has 12 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 10/15/2020.
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. Angelini Francesco Acraf Spa's FEI number is 1000399573.
What types of violations has Angelini Francesco Acraf Spa received?
Angelini Francesco Acraf Spa has been cited for 6 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 Angelini Francesco Acraf Spa come from?
All FDA import refusal data for Angelini Francesco Acraf 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.