DAY PHARMA EIRELI- ME
⚠️ High Risk
FEI: 3016815740 • Center • BRAZIL
FEI Number
3016815740
Location
Center
Country
BRAZILAddress
Itu/Sp Floriano Pe, 1433, , Center, , Brazil
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).
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 |
|---|---|---|---|
| 7/2/2024 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2024 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2024 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2024 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2024 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/26/2024 | 64RDY17ANASTROZOLE (HORMONE) | Division of Southeast Imports (DSEI) | |
| 3/26/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/26/2024 | 54ABY13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2021 | 65PDY99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2021 | 65PDY99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2021 | 65PDY99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2020 | 66SDY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2020 | 61NDY60TRAZODONE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DAY PHARMA EIRELI- ME's FDA import refusal history?
DAY PHARMA EIRELI- ME (FEI: 3016815740) has 14 FDA import refusal record(s) in our database, spanning from 9/18/2020 to 7/2/2024.
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. DAY PHARMA EIRELI- ME's FEI number is 3016815740.
What types of violations has DAY PHARMA EIRELI- ME received?
DAY PHARMA EIRELI- ME has been cited for 2 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 DAY PHARMA EIRELI- ME come from?
All FDA import refusal data for DAY PHARMA EIRELI- ME 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.