Bidachem S.p.A.
⚠️ Moderate Risk
FEI: 3002806598 • Fornovo San Giovanni, Bergamo • ITALY
FEI Number
3002806598
Location
Fornovo San Giovanni, Bergamo
Country
ITALYAddress
Strada Statale 11, , Fornovo San Giovanni, 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 |
|---|---|---|---|
| 2/15/2013 | 65TCS02CROTAMITON (SCABICIDE) | 16DIRECTIONS | Baltimore District Office (BLT-DO) |
| 9/7/2012 | 62VCS12RIBAVIRIN (ANTI-VIRAL) | Baltimore District Office (BLT-DO) | |
| 7/5/2012 | 62GIS46KETOPROFEN (ANTI-INFLAMMATORY) | Baltimore District Office (BLT-DO) | |
| 6/28/2012 | 62VCS12RIBAVIRIN (ANTI-VIRAL) | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Bidachem S.p.A.'s FDA import refusal history?
Bidachem S.p.A. (FEI: 3002806598) has 4 FDA import refusal record(s) in our database, spanning from 6/28/2012 to 2/15/2013.
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. Bidachem S.p.A.'s FEI number is 3002806598.
What types of violations has Bidachem S.p.A. received?
Bidachem S.p.A. 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 Bidachem S.p.A. come from?
All FDA import refusal data for Bidachem 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.