ACS Dobfar S.p.A.
⚠️ Moderate Risk
FEI: 3002807084 • Verona, Verona • ITALY
FEI Number
3002807084
Location
Verona, Verona
Country
ITALYAddress
Via Alessandro Fleming 2, , Verona, Verona, 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
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).
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).
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.
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 |
|---|---|---|---|
| 7/6/2017 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/8/2017 | 62GIA41IBUPROFEN (ANTI-INFLAMMATORY) | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 4/4/2017 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/24/2016 | 63BLQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/25/2015 | 62GAY99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/16/2015 | 61XAY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/20/2012 | 66TDC01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2008 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2007 | 63BDB25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/1/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ACS Dobfar S.p.A.'s FDA import refusal history?
ACS Dobfar S.p.A. (FEI: 3002807084) has 11 FDA import refusal record(s) in our database, spanning from 2/1/2006 to 7/6/2017.
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. ACS Dobfar S.p.A.'s FEI number is 3002807084.
What types of violations has ACS Dobfar S.p.A. received?
ACS Dobfar S.p.A. has been cited for 4 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 ACS Dobfar S.p.A. come from?
All FDA import refusal data for ACS Dobfar 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.