FIAD INTERNATIONAL S.A.S.
⚠️ Moderate Risk
FEI: 3004577358 • Envigado, Antioquia • COLOMBIA
FEI Number
3004577358
Location
Envigado, Antioquia
Country
COLOMBIAAddress
Calle 49 Sur 43a 26 Local 401, , Envigado, Antioquia, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is FIAD INTERNATIONAL S.A.S.'s FDA import refusal history?
FIAD INTERNATIONAL S.A.S. (FEI: 3004577358) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2017 to 11/22/2017.
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. FIAD INTERNATIONAL S.A.S.'s FEI number is 3004577358.
What types of violations has FIAD INTERNATIONAL S.A.S. received?
FIAD INTERNATIONAL S.A.S. 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 FIAD INTERNATIONAL S.A.S. come from?
All FDA import refusal data for FIAD INTERNATIONAL S.A.S. 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.