Quimica Sintetica, SA
⚠️ Moderate Risk
FEI: 3002807965 • Alcala De Henares, Madrid • SPAIN
FEI Number
3002807965
Location
Alcala De Henares, Madrid
Country
SPAINAddress
Calle Dulcinea S/N, , Alcala De Henares, Madrid, 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.
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).
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 |
|---|---|---|---|
| 9/18/2017 | 62KCS10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2016 | 61ECS08LORATADINE (ANTI-ASTHMATIC) | Division of West Coast Imports (DWCI) | |
| 1/28/2003 | 61NCS66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 7/2/2002 | 61NDS29FLUOXETINE (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Quimica Sintetica, SA's FDA import refusal history?
Quimica Sintetica, SA (FEI: 3002807965) has 4 FDA import refusal record(s) in our database, spanning from 7/2/2002 to 9/18/2017.
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. Quimica Sintetica, SA's FEI number is 3002807965.
What types of violations has Quimica Sintetica, SA received?
Quimica Sintetica, SA 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 Quimica Sintetica, SA come from?
All FDA import refusal data for Quimica Sintetica, 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.