Menadiona S.A.
⚠️ Moderate Risk
FEI: 1000242648 • Palafolls, Barcelona • SPAIN
FEI Number
1000242648
Location
Palafolls, Barcelona
Country
SPAINAddress
Carr. Nacional Ii Km 680., Pol. Ind., Poligono Sector Mas Puigvert Oest 5, Palafolls, Barcelona, Spain
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
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.
STD IDENT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/25/2018 | 54ADY20MENADIONE (VITAMIN) | Division of Southeast Imports (DSEI) | |
| 7/20/2005 | 65QCS60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
| 2/17/2005 | 61NCS69GABAPENTIN (ANTI-DEPRESSANT) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Menadiona S.A.'s FDA import refusal history?
Menadiona S.A. (FEI: 1000242648) has 3 FDA import refusal record(s) in our database, spanning from 2/17/2005 to 1/25/2018.
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. Menadiona S.A.'s FEI number is 1000242648.
What types of violations has Menadiona S.A. received?
Menadiona S.A. has been cited for 5 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 Menadiona S.A. come from?
All FDA import refusal data for Menadiona S.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.