ACS Dobfar SPA (Plant #2)
⚠️ Moderate Risk
FEI: 3002806297 • Tribiano, Milan • ITALY
FEI Number
3002806297
Location
Tribiano, Milan
Country
ITALYAddress
Viale Addetta 12-3/5, 2 A, Tribiano, Milan, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2011 | 56CDZ68CEFTIBUTEN (CEPHALOSPORINS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/5/2008 | 56YIL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/27/2006 | 56CCS52CEFDINIR (CEPHALOSPORINS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/27/2006 | 56YCS99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/27/2006 | 56CCS99CEPHALOSPORIN N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/1/2005 | 56CIY58CEFOPERAZONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2004 | 56CCS62CEFOXITIN SODIUM (CEPHALOSPORINS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/19/2004 | 56CAS99CEPHALOSPORIN N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/19/2004 | 56CAS99CEPHALOSPORIN N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ACS Dobfar SPA (Plant #2)'s FDA import refusal history?
ACS Dobfar SPA (Plant #2) (FEI: 3002806297) has 9 FDA import refusal record(s) in our database, spanning from 6/19/2004 to 12/7/2011.
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 SPA (Plant #2)'s FEI number is 3002806297.
What types of violations has ACS Dobfar SPA (Plant #2) received?
ACS Dobfar SPA (Plant #2) has been cited for 3 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 SPA (Plant #2) come from?
All FDA import refusal data for ACS Dobfar SPA (Plant #2) 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.