Hospital De La San
⚠️ Moderate Risk
FEI: 3005693751 • Barakaldo, Bizkaia • SPAIN
FEI Number
3005693751
Location
Barakaldo, Bizkaia
Country
SPAINAddress
Plaza Cruces - Gurutzeta Sn, , Barakaldo, Bizkaia, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | New Orleans District Office (NOL-DO) |
| 10/7/2009 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/7/2009 | 66BBY99STIMULANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/7/2009 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/7/2009 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/7/2009 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hospital De La San's FDA import refusal history?
Hospital De La San (FEI: 3005693751) has 6 FDA import refusal record(s) in our database, spanning from 10/7/2009 to 10/7/2009.
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. Hospital De La San's FEI number is 3005693751.
What types of violations has Hospital De La San received?
Hospital De La San 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 Hospital De La San come from?
All FDA import refusal data for Hospital De La San 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.