Tecnoquimicas Sa
⚠️ Moderate Risk
FEI: 3011267882 • Cali • COLOMBIA
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).
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 |
|---|---|---|---|
| 1/11/2022 | 66NCE03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2020 | 61PDB26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 10/22/2020 | 61JCA16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 10/22/2020 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Southeast Imports (DSEI) | |
| 10/22/2020 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 7/20/2020 | 61EAA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2020 | 61EAA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2020 | 66JDA05THYROID (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/10/2017 | 62ODY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tecnoquimicas Sa's FDA import refusal history?
Tecnoquimicas Sa (FEI: 3011267882) has 9 FDA import refusal record(s) in our database, spanning from 10/10/2017 to 1/11/2022.
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. Tecnoquimicas Sa's FEI number is 3011267882.
What types of violations has Tecnoquimicas Sa received?
Tecnoquimicas Sa 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 Tecnoquimicas Sa come from?
All FDA import refusal data for Tecnoquimicas 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.