Laboratorios Funat SAS
⚠️ High Risk
FEI: 3007271231 • Sabaneta, Antioquia • COLOMBIA
FEI Number
3007271231
Location
Sabaneta, Antioquia
Country
COLOMBIAAddress
Carrera 47f 79s 77, , Sabaneta, Antioquia, 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2025 | 54ACY99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2024 | 62GDL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2018 | 54FDR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2017 | 54KYY03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 12/21/2017 | 54KYY03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 7/9/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 330UNSAFE COL | Florida District Office (FLA-DO) |
| 5/27/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
| 5/27/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Laboratorios Funat SAS's FDA import refusal history?
Laboratorios Funat SAS (FEI: 3007271231) has 8 FDA import refusal record(s) in our database, spanning from 5/27/2014 to 4/28/2025.
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. Laboratorios Funat SAS's FEI number is 3007271231.
What types of violations has Laboratorios Funat SAS received?
Laboratorios Funat SAS 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 Laboratorios Funat SAS come from?
All FDA import refusal data for Laboratorios Funat SAS 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.