Industriale Chimica S.R.L.
⚠️ Moderate Risk
FEI: 3001734129 • Saronno, Varese • ITALY
FEI Number
3001734129
Location
Saronno, Varese
Country
ITALYAddress
Via Edvard Hagerup Grieg 13, , Saronno, Varese, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2018 | 64TCS99IMMUNOSUPPRESS N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/23/2018 | 64TCS99IMMUNOSUPPRESS N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 7/23/2015 | 64GCS29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/21/2014 | 61ECS04BUDESONIDE (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 8/21/2014 | 61ECS04BUDESONIDE (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 12/19/2012 | 61ECS04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/6/2009 | 64RQR99HORMONE N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/31/2002 | 61NCS65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Industriale Chimica S.R.L.'s FDA import refusal history?
Industriale Chimica S.R.L. (FEI: 3001734129) has 8 FDA import refusal record(s) in our database, spanning from 12/31/2002 to 3/23/2018.
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. Industriale Chimica S.R.L.'s FEI number is 3001734129.
What types of violations has Industriale Chimica S.R.L. received?
Industriale Chimica S.R.L. 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 Industriale Chimica S.R.L. come from?
All FDA import refusal data for Industriale Chimica S.R.L. 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.