Corden Pharma Bergamo SPA
⚠️ Moderate Risk
FEI: 3002806963 • Treviglio, Bergamo • ITALY
FEI Number
3002806963
Location
Treviglio, Bergamo
Country
ITALYAddress
Via Bergamo 121, , Treviglio, Bergamo, 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.
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 |
|---|---|---|---|
| 12/20/2010 | 61WCS04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | Chicago District Office (CHI-DO) |
| 5/14/2009 | 65QIS21METAXALONE (RELAXANT) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 6/10/2005 | 60LCS85MESALAMINE (ANALGESIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/27/2002 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/27/2002 | 60LCS85MESALAMINE (ANALGESIC) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Corden Pharma Bergamo SPA's FDA import refusal history?
Corden Pharma Bergamo SPA (FEI: 3002806963) has 5 FDA import refusal record(s) in our database, spanning from 2/27/2002 to 12/20/2010.
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. Corden Pharma Bergamo SPA's FEI number is 3002806963.
What types of violations has Corden Pharma Bergamo SPA received?
Corden Pharma Bergamo SPA has been cited for 2 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 Corden Pharma Bergamo SPA come from?
All FDA import refusal data for Corden Pharma Bergamo SPA 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.