Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
⚠️ High Risk
FEI: 3005491771 • Barcarena, Lisbon • PORTUGAL
FEI Number
3005491771
Location
Barcarena, Lisbon
Country
PORTUGALAddress
Estrada Consiglieri Pedroso 69-B, Queluz De Baixo, Barcarena, Lisbon, Portugal
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2024 | 60WDC16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/23/2024 | 60WDB16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/6/2022 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/22/2021 | 60WAC16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/2/2021 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/10/2021 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/1/2018 | 60WAB16MEBENDAZOLE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 9/20/2017 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/4/2016 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/4/2016 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 7/16/2015 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | Baltimore District Office (BLT-DO) | |
| 7/16/2015 | 56GCO99ANTIFUNGAL N.E.C. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Lusomedicamenta Sociedade Tecnica Farmaceutica S.A's FDA import refusal history?
Lusomedicamenta Sociedade Tecnica Farmaceutica S.A (FEI: 3005491771) has 12 FDA import refusal record(s) in our database, spanning from 7/16/2015 to 6/27/2024.
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. Lusomedicamenta Sociedade Tecnica Farmaceutica S.A's FEI number is 3005491771.
What types of violations has Lusomedicamenta Sociedade Tecnica Farmaceutica S.A received?
Lusomedicamenta Sociedade Tecnica Farmaceutica S.A has been cited for 6 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 Lusomedicamenta Sociedade Tecnica Farmaceutica S.A come from?
All FDA import refusal data for Lusomedicamenta Sociedade Tecnica Farmaceutica 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.