Zaklady Farmaceutyczne Polpharma S.A.
⚠️ Moderate Risk
FEI: 3002807920 • Starogard Gdanski, Pomorskie • POLAND
FEI Number
3002807920
Location
Starogard Gdanski, Pomorskie
Country
POLANDAddress
Ul. Pelplinska 19, , Starogard Gdanski, Pomorskie, Poland
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 9/13/2019 | 61PCR99ANTI-DIABETIC N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/24/2017 | 56YCA99ANTIBIOTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 60WCA31PYRANTEL PAMOATE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 6/19/2012 | 60SAU25RANITIDINE HYDROCHLORIDE (ANTACID) | New York District Office (NYK-DO) | |
| 4/26/2012 | 60SAP99ANTACID, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/15/2008 | 63AIS02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/7/2005 | 61GJS59SULFAMOXOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 11/7/2005 | 61GJS59SULFAMOXOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 11/7/2005 | 61GJS59SULFAMOXOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 11/7/2005 | 61GJS59SULFAMOXOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 11/7/2005 | 61GJS59SULFAMOXOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 8/31/2004 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/30/2004 | 62KIA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Zaklady Farmaceutyczne Polpharma S.A.'s FDA import refusal history?
Zaklady Farmaceutyczne Polpharma S.A. (FEI: 3002807920) has 15 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 9/13/2019.
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. Zaklady Farmaceutyczne Polpharma S.A.'s FEI number is 3002807920.
What types of violations has Zaklady Farmaceutyczne Polpharma S.A. received?
Zaklady Farmaceutyczne Polpharma S.A. has been cited for 6 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 Zaklady Farmaceutyczne Polpharma S.A. come from?
All FDA import refusal data for Zaklady Farmaceutyczne Polpharma 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.