Curia Spain SAU
⚠️ Moderate Risk
FEI: 3002996872 • Boecillo, Valladolid • SPAIN
FEI Number
3002996872
Location
Boecillo, Valladolid
Country
SPAINAddress
Parcela 105, Parque Tecnologico De Boecillo, Boecillo, Valladolid, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2022 | 64LIY61TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2017 | 61XIY48OLOPATADINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2016 | 61UCS07FULVESTRANT | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 12/3/2015 | 64LAS52PREDNISOLONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/10/2014 | 64LAR44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/20/2010 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2004 | 64LIS07BETAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/9/2004 | 64LIS04BETAMETHASONE ACETATE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/15/2003 | 65JCS21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/26/2002 | 64LAY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 4/12/2002 | 64LAY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Curia Spain SAU's FDA import refusal history?
Curia Spain SAU (FEI: 3002996872) has 11 FDA import refusal record(s) in our database, spanning from 4/12/2002 to 10/21/2022.
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. Curia Spain SAU's FEI number is 3002996872.
What types of violations has Curia Spain SAU received?
Curia Spain SAU has been cited for 3 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 Curia Spain SAU come from?
All FDA import refusal data for Curia Spain SAU 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.