Tosara Pharma Limited
⚠️ Moderate Risk
FEI: 3004717968 • Dublin 13, Co. DUBLIN • IRELAND
FEI Number
3004717968
Location
Dublin 13, Co. DUBLIN
Country
IRELANDAddress
Unit 146, Baldoyle Industrial Estate, Dublin 13, Co. DUBLIN, Ireland
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).
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.
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 in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 65LBO15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/14/2023 | 65LAJ15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/9/2022 | 62FAJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 11/7/2022 | 65LBY99PROTECTANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2022 | 65LBY99PROTECTANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/8/2022 | 65LAJ99PROTECTANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2022 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/26/2016 | 62WDJ09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | New Orleans District Office (NOL-DO) | |
| 6/4/2012 | 62WBJ09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/11/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 5/3/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 7/26/2006 | 56AYO99PENICILLIN NATURAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tosara Pharma Limited's FDA import refusal history?
Tosara Pharma Limited (FEI: 3004717968) has 12 FDA import refusal record(s) in our database, spanning from 7/26/2006 to 3/9/2023.
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. Tosara Pharma Limited's FEI number is 3004717968.
What types of violations has Tosara Pharma Limited received?
Tosara Pharma Limited has been cited for 5 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 Tosara Pharma Limited come from?
All FDA import refusal data for Tosara Pharma Limited 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.