VUAB Pharma a.s.
⚠️ Moderate Risk
FEI: 3003002370 • Roztoky • CZECH REPUBLIC
FEI Number
3003002370
Location
Roztoky
Country
CZECH REPUBLICAddress
Vltavska 53, , Roztoky, , Czech Republic
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).
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 |
|---|---|---|---|
| 6/23/2009 | 56GCS50NYSTATIN (ANTIFUNGAL) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 3/30/2009 | 56GCZ50NYSTATIN (ANTIFUNGAL) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
| 4/10/2007 | 56GCS50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 2/17/2006 | 56GCS50NYSTATIN (ANTIFUNGAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is VUAB Pharma a.s.'s FDA import refusal history?
VUAB Pharma a.s. (FEI: 3003002370) has 4 FDA import refusal record(s) in our database, spanning from 2/17/2006 to 6/23/2009.
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. VUAB Pharma a.s.'s FEI number is 3003002370.
What types of violations has VUAB Pharma a.s. received?
VUAB Pharma a.s. has been cited for 3 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 VUAB Pharma a.s. come from?
All FDA import refusal data for VUAB Pharma a.s. 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.