PLIVA Hrvatska d.o.o.
⚠️ Moderate Risk
FEI: 3002807904 • Zagreb, Grad Zagreb • CROATIA
FEI Number
3002807904
Location
Zagreb, Grad Zagreb
Country
CROATIAAddress
Prilaz Baruna Filipovica 25, , 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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2020 | 56IDY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2019 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2017 | 63JIS99CHELATING AGENT N.E.C. | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 5/23/2017 | 60SCA23METOCLOPRAMIDE (ANTACID) | Division of Northeast Imports (DNEI) | |
| 2/3/2016 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/13/2012 | 66MIY83HYDROXYZINE HCL (TRANQUILIZER) | New Orleans District Office (NOL-DO) | |
| 1/7/2012 | 62JCR13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/30/2004 | 62GIP89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/20/2002 | 61HIS99ANTI-BACTERIAL, N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PLIVA Hrvatska d.o.o.'s FDA import refusal history?
PLIVA Hrvatska d.o.o. (FEI: 3002807904) has 9 FDA import refusal record(s) in our database, spanning from 11/20/2002 to 5/14/2020.
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 Hrvatska d.o.o.'s FEI number is 3002807904.
What types of violations has PLIVA Hrvatska d.o.o. received?
PLIVA Hrvatska d.o.o. 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 PLIVA Hrvatska d.o.o. come from?
All FDA import refusal data for PLIVA Hrvatska d.o.o. 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.