KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A.
⚠️ Moderate Risk
FEI: 2000002184 • Cracow, Malopolskie • POLAND
FEI Number
2000002184
Location
Cracow, Malopolskie
Country
POLANDAddress
Ul. Kazimierza Chalupnika 14, , Cracow, Malopolskie, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 10/25/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 10/25/2006 | 62FBL99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A.'s FDA import refusal history?
KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A. (FEI: 2000002184) has 3 FDA import refusal record(s) in our database, spanning from 10/25/2006 to 10/25/2006.
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. KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A.'s FEI number is 2000002184.
What types of violations has KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A. received?
KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A. has been cited for 1 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 KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE S.A. come from?
All FDA import refusal data for KRAKOWSKIE ZAKLADY ZIELARSKIE "HERBAPOL" W KRAKOWIE 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.