Grabikowski-Grabikowska Pphu Inex
⚠️ Moderate Risk
FEI: 3010248636 • Gizycko, Warminsko-mazurskie • POLAND
FEI Number
3010248636
Location
Gizycko, Warminsko-mazurskie
Country
POLANDAddress
Ul Bialostocka 40, , Gizycko, Warminsko-mazurskie, 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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VJY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VQY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2013 | 66VMY99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Grabikowski-Grabikowska Pphu Inex's FDA import refusal history?
Grabikowski-Grabikowska Pphu Inex (FEI: 3010248636) has 9 FDA import refusal record(s) in our database, spanning from 7/23/2013 to 7/23/2013.
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. Grabikowski-Grabikowska Pphu Inex's FEI number is 3010248636.
What types of violations has Grabikowski-Grabikowska Pphu Inex received?
Grabikowski-Grabikowska Pphu Inex has been cited for 3 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 Grabikowski-Grabikowska Pphu Inex come from?
All FDA import refusal data for Grabikowski-Grabikowska Pphu Inex 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.