Recordati Industria Chimica E Farmaceutica S.P.A
⚠️ High Risk
FEI: 3002579035 • Milan, Milan • ITALY
FEI Number
3002579035
Location
Milan, Milan
Country
ITALYAddress
Via Matteo Civitali 01, , Milan, 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
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).
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.
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.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2025 | 62OCE18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2022 | 56BDB57BACAMPICILLIN HYDROCHLORIDE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 61WIJ99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 61WCE46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2016 | 65QDA47PAPAVERINE HCL (RELAXANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/4/2014 | 61TCT06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | Minneapolis District Office (MIN-DO) | |
| 7/26/2010 | 61MCS24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/21/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2006 | 60TCA05CIMETIDINE (ANTAGONIST) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/2/2006 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 5/21/2004 | 61NCL99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-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: 3002579035) has 11 FDA import refusal record(s) in our database, spanning from 5/21/2004 to 10/6/2025.
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 3002579035.
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 6 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.