Altea Farmaceutica
⚠️ High Risk
FEI: 3010022736 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3010022736
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Calle 10 65 28, , Bogota, Cundinamarca, Colombia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 1/21/2026 | 65LDK02ALLANTOIN (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 1/6/2026 | 64HDY02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2025 | 62SCY99ANTI-SEBORRHEIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 62FCY99ANTI-INFECTIVE, TOPICAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/7/2025 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2024 | 54AGY12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2023 | 66GDY25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2023 | 65LCY06CALAMINE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2023 | 62FCJ53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2021 | 54AGA02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 60QCY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 62GDJ99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2020 | 66KDY01METHIMAZOLE (THYROID INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2014 | 61KCB16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2014 | 60SCA26SUCRALFATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Altea Farmaceutica's FDA import refusal history?
Altea Farmaceutica (FEI: 3010022736) has 16 FDA import refusal record(s) in our database, spanning from 4/1/2014 to 1/21/2026.
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. Altea Farmaceutica's FEI number is 3010022736.
What types of violations has Altea Farmaceutica received?
Altea Farmaceutica 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 Altea Farmaceutica come from?
All FDA import refusal data for Altea Farmaceutica 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.