Recordati Industria Chimica E Farmaceutica S.p.A.
⚠️ High Risk
FEI: 3002807989 • Aprilia, Latina • ITALY
FEI Number
3002807989
Location
Aprilia, Latina
Country
ITALYAddress
Via Mediana Cisterna 4, , Aprilia, Latina, 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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2024 | 65UBY02TRIBENOSIDE (SCLEROSING AGENT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/26/2018 | 61XAS18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/29/2015 | 65QCT47PAPAVERINE HCL (RELAXANT) | San Francisco District Office (SAN-DO) | |
| 10/30/2012 | 61TDA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/14/2008 | 61MCS24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/12/2008 | 61XCS18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Recordati Industria Chimica E Farmaceutica S.p.A.'s FDA import refusal history?
Recordati Industria Chimica E Farmaceutica S.p.A. (FEI: 3002807989) has 6 FDA import refusal record(s) in our database, spanning from 7/12/2008 to 8/30/2024.
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. Recordati Industria Chimica E Farmaceutica S.p.A.'s FEI number is 3002807989.
What types of violations has Recordati Industria Chimica E Farmaceutica S.p.A. received?
Recordati Industria Chimica E Farmaceutica 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 Recordati Industria Chimica E Farmaceutica S.p.A. come from?
All FDA import refusal data for Recordati Industria Chimica E Farmaceutica 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.