Takeda Italia Farmaceutici S.P.A.
⚠️ Moderate Risk
FEI: 3004110777 • Roma, RM • ITALY
FEI Number
3004110777
Location
Roma, RM
Country
ITALYAddress
Via Elio Vittorini, 129, , Roma, RM, 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
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).
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).
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
Frequently Asked Questions
What is Takeda Italia Farmaceutici S.P.A.'s FDA import refusal history?
Takeda Italia Farmaceutici S.P.A. (FEI: 3004110777) has 3 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 11/9/2018.
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. Takeda Italia Farmaceutici S.P.A.'s FEI number is 3004110777.
What types of violations has Takeda Italia Farmaceutici S.P.A. received?
Takeda Italia Farmaceutici S.P.A. 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 Takeda Italia Farmaceutici S.P.A. come from?
All FDA import refusal data for Takeda Italia Farmaceutici 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.