AGEPHA PHARMA S.R.O.
⚠️ High Risk
FEI: 3017156886 • Senec, Bratislava • SLOVAKIA
FEI Number
3017156886
Location
Senec, Bratislava
Country
SLOVAKIAAddress
Dialnicna Cesta 5, , Senec, Bratislava, Slovakia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/22/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/22/2024 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/22/2024 | 62GBY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/13/2024 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/9/2022 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 60CBL51TETRAHYDROZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AGEPHA PHARMA S.R.O.'s FDA import refusal history?
AGEPHA PHARMA S.R.O. (FEI: 3017156886) has 7 FDA import refusal record(s) in our database, spanning from 3/1/2021 to 10/22/2024.
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. AGEPHA PHARMA S.R.O.'s FEI number is 3017156886.
What types of violations has AGEPHA PHARMA S.R.O. received?
AGEPHA PHARMA S.R.O. 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 AGEPHA PHARMA S.R.O. come from?
All FDA import refusal data for AGEPHA PHARMA S.R.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.