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Innochem S.A.

⚠️ Moderate Risk

FEI: 3003414736 • Meerhout, Antwerp • BELGIUM

FEI

FEI Number

3003414736

📍

Location

Meerhout, Antwerp

🇧🇪

Country

BELGIUM
🏢

Address

Burgemeester Adriaensenlaan 66, , Meerhout, Antwerp, Belgium

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/1/2023
Latest Refusal
12/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
57.3×20%
Frequency
10.0×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
12/1/2023
88PPMGENERAL PURPOSE REAGENT
16DIRECTIONS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Innochem S.A.'s FDA import refusal history?

Innochem S.A. (FEI: 3003414736) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2023 to 12/1/2023.

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. Innochem S.A.'s FEI number is 3003414736.

What types of violations has Innochem S.A. received?

Innochem S.A. has been cited for 1 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 Innochem S.A. come from?

All FDA import refusal data for Innochem S.A. 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.