Curia Italy S.r.l.
⚠️ Moderate Risk
FEI: 1000330416 • Origgio, Varese • ITALY
FEI Number
1000330416
Location
Origgio, Varese
Country
ITALYAddress
Viale Europa 5, , Origgio, 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.
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.
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 |
|---|---|---|---|
| 12/3/2022 | 56EDS61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | Division of Southeast Imports (DSEI) | |
| 6/9/2017 | 64BCR14CHLORTHALIDONE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 6/9/2017 | 64BCR14CHLORTHALIDONE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 6/9/2017 | 64BCC14CHLORTHALIDONE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 9/5/2013 | 64BCS14CHLORTHALIDONE (DIURETIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/15/2009 | 56EIS61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | New York District Office (NYK-DO) | |
| 10/17/2007 | 56ECS60MINOCYCLINE (TETRACYCLINES) | New York District Office (NYK-DO) | |
| 2/23/2005 | 56ECS61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/31/2002 | 64BBS14CHLORTHALIDONE (DIURETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Curia Italy S.r.l.'s FDA import refusal history?
Curia Italy S.r.l. (FEI: 1000330416) has 9 FDA import refusal record(s) in our database, spanning from 12/31/2002 to 12/3/2022.
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. Curia Italy S.r.l.'s FEI number is 1000330416.
What types of violations has Curia Italy S.r.l. received?
Curia Italy S.r.l. has been cited for 4 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 Curia Italy S.r.l. come from?
All FDA import refusal data for Curia Italy 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.