Interpharma Praha A.S.
⚠️ Moderate Risk
FEI: 3002807299 • Prague 12, Prague • CZECH REPUBLIC
FEI Number
3002807299
Location
Prague 12, Prague
Country
CZECH REPUBLICAddress
Komoranska 955/61, , Prague 12, Prague, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/11/2005 | 62FIJ24MAFENIDE ACETATE (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 4/17/2002 | 62FAR24MAFENIDE ACETATE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 11/23/2001 | 62FCR24MAFENIDE ACETATE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Interpharma Praha A.S.'s FDA import refusal history?
Interpharma Praha A.S. (FEI: 3002807299) has 3 FDA import refusal record(s) in our database, spanning from 11/23/2001 to 2/11/2005.
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. Interpharma Praha A.S.'s FEI number is 3002807299.
What types of violations has Interpharma Praha A.S. received?
Interpharma Praha A.S. 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 Interpharma Praha A.S. come from?
All FDA import refusal data for Interpharma Praha 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.