Bieffe Medital, S.A.
⚠️ Moderate Risk
FEI: 3005164365 • Sabinanigo, Huesca • SPAIN
FEI Number
3005164365
Location
Sabinanigo, Huesca
Country
SPAINAddress
Carretera N - 260 S/N, , Sabinanigo, Huesca, 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
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 |
|---|---|---|---|
| 3/23/2017 | 65RCK17RINGER'S INJECTION, LACTATED (REPLENISHER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2007 | 65RCK17RINGER'S INJECTION, LACTATED (REPLENISHER) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 61LCK20ANTI-COAGULANT CITRATE DEXTROSE SOLUTION | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bieffe Medital, S.A.'s FDA import refusal history?
Bieffe Medital, S.A. (FEI: 3005164365) has 3 FDA import refusal record(s) in our database, spanning from 4/24/2007 to 3/23/2017.
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. Bieffe Medital, S.A.'s FEI number is 3005164365.
What types of violations has Bieffe Medital, S.A. received?
Bieffe Medital, S.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 Bieffe Medital, S.A. come from?
All FDA import refusal data for Bieffe Medital, 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.