ALMIRALL SA
⚠️ Moderate Risk
FEI: 3012540909 • Barcelona, Barcelona • SPAIN
FEI Number
3012540909
Location
Barcelona, Barcelona
Country
SPAINAddress
Ronda General Mitre 151, , Barcelona, Barcelona, Spain
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 5/5/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 12/5/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 12/5/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 12/5/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 9/29/2011 | 62TCF07PANTOPRAZOLE SODIUM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/15/2005 | 62GCP99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 60XCB17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2004 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ALMIRALL SA's FDA import refusal history?
ALMIRALL SA (FEI: 3012540909) has 9 FDA import refusal record(s) in our database, spanning from 9/22/2004 to 5/5/2021.
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. ALMIRALL SA's FEI number is 3012540909.
What types of violations has ALMIRALL SA received?
ALMIRALL SA has been cited for 4 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 ALMIRALL SA come from?
All FDA import refusal data for ALMIRALL SA 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.