Towa Pharmaceutical Europe, S.L.
✅ Low Risk
FEI: 3003121577 • Martorelles, Barcelona • SPAIN
FEI Number
3003121577
Location
Martorelles, Barcelona
Country
SPAINAddress
Calle De Sant Marti 75-97, , Martorelles, Barcelona, Spain
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2020 | 61NCF99ANTI-DEPRESSANT N.E.C. | 333LACKS FIRM | Division of Southwest Imports (DSWI) |
| 4/7/2020 | 61NCF99ANTI-DEPRESSANT N.E.C. | 333LACKS FIRM | Division of Southwest Imports (DSWI) |
| 9/4/2008 | 62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Towa Pharmaceutical Europe, S.L.'s FDA import refusal history?
Towa Pharmaceutical Europe, S.L. (FEI: 3003121577) has 3 FDA import refusal record(s) in our database, spanning from 9/4/2008 to 4/7/2020.
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. Towa Pharmaceutical Europe, S.L.'s FEI number is 3003121577.
What types of violations has Towa Pharmaceutical Europe, S.L. received?
Towa Pharmaceutical Europe, S.L. 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 Towa Pharmaceutical Europe, S.L. come from?
All FDA import refusal data for Towa Pharmaceutical Europe, S.L. 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.