ImportRefusal LogoImportRefusal

BTSA, Biotecnologias Aplicadas

⚠️ High Risk

FEI: 3009988272 • Alcala de Henares, Madrid • SPAIN

FEI

FEI Number

3009988272

📍

Location

Alcala de Henares, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Calle Arroba 4 28805, , Alcala de Henares, Madrid, Spain

High Risk

FDA Import Risk Assessment

60.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
2
Unique Violations
7/29/2025
Latest Refusal
6/24/2025
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
17.7×30%
Recency
90.9×20%
Frequency
20.0×10%
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

2382×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

DateProductViolationsDivision
7/29/2025
54ACY16VITAMIN E (TOCOPHEROL)
238UNSAFE ADD
Division of West Coast Imports (DWCI)
6/24/2025
23KGH09QUINOA SEED (EDIBLE SEED)
2120UNSFDIETSP
238UNSAFE ADD
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is BTSA, Biotecnologias Aplicadas's FDA import refusal history?

BTSA, Biotecnologias Aplicadas (FEI: 3009988272) has 2 FDA import refusal record(s) in our database, spanning from 6/24/2025 to 7/29/2025.

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. BTSA, Biotecnologias Aplicadas's FEI number is 3009988272.

What types of violations has BTSA, Biotecnologias Aplicadas received?

BTSA, Biotecnologias Aplicadas 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 BTSA, Biotecnologias Aplicadas come from?

All FDA import refusal data for BTSA, Biotecnologias Aplicadas 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.