Pliva Croatia
⚠️ Moderate Risk
FEI: 3008612636 • Zagreb, Grad Zagreb • CROATIA
FEI Number
3008612636
Location
Zagreb, Grad Zagreb
Country
CROATIAAddress
Ulica Grada Vukovara 49, , Zagreb, Grad Zagreb, Croatia
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 |
|---|---|---|---|
| 11/22/2005 | 64BBB25HYDROCHLOROTHIAZIDE (DIURETIC) | New York District Office (NYK-DO) | |
| 2/17/2005 | 61GDS65SULFISOXAZOLE ACETYL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 2/4/2005 | 61GDS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pliva Croatia's FDA import refusal history?
Pliva Croatia (FEI: 3008612636) has 3 FDA import refusal record(s) in our database, spanning from 2/4/2005 to 11/22/2005.
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. Pliva Croatia's FEI number is 3008612636.
What types of violations has Pliva Croatia received?
Pliva Croatia 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 Pliva Croatia come from?
All FDA import refusal data for Pliva Croatia 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.