Indena S.p.A.
⚠️ High Risk
FEI: 1000280888 • Settala, Milan • ITALY
FEI Number
1000280888
Location
Settala, Milan
Country
ITALYAddress
Via Don Giovanni Minzoni 6, , Settala, Milan, 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
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2023 | 62ISS91PACLITAXEL (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 3/23/2023 | 62ISS91PACLITAXEL (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 3/23/2023 | 62ISS91PACLITAXEL (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 3/4/2021 | 62CCT51RESERPINE (ANTI-HYPERTENSIVE) | 3871708NODIREC | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 60QIK99ANESTHETIC, N.E.C. | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 1/3/2017 | 66FAR05COLCHICINE (SUPPRESSANT) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 2/10/2012 | 62IIR91PACLITAXEL (ANTI-NEOPLASTIC) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 2/10/2012 | 62IIR91PACLITAXEL (ANTI-NEOPLASTIC) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 6/26/2007 | 54YBR04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 2920PESTICIDES | Seattle District Office (SEA-DO) |
| 6/26/2007 | 54YBR04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 2920PESTICIDES | Seattle District Office (SEA-DO) |
| 6/12/2007 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Seattle District Office (SEA-DO) |
| 6/12/2007 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Seattle District Office (SEA-DO) |
| 6/12/2007 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Seattle District Office (SEA-DO) |
| 4/9/2007 | 54FBT12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 2920PESTICIDES | Seattle District Office (SEA-DO) |
| 12/21/2004 | 62IDY91PACLITAXEL (ANTI-NEOPLASTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/5/2004 | 62IDS91PACLITAXEL (ANTI-NEOPLASTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Indena S.p.A.'s FDA import refusal history?
Indena S.p.A. (FEI: 1000280888) has 16 FDA import refusal record(s) in our database, spanning from 8/5/2004 to 3/23/2023.
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. Indena S.p.A.'s FEI number is 1000280888.
What types of violations has Indena S.p.A. received?
Indena S.p.A. has been cited for 5 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 Indena S.p.A. come from?
All FDA import refusal data for Indena 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.