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Aisis OOD

⚠️ Moderate Risk

FEI: 3003293568 • Kaspichan, oblast Shumen • BULGARIA

FEI

FEI Number

3003293568

📍

Location

Kaspichan, oblast Shumen

🇧🇬

Country

BULGARIA
🏢

Address

Madarski Konnik Street 12, , Kaspichan, oblast Shumen, Bulgaria

Moderate Risk

FDA Import Risk Assessment

49.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
10/22/2015
Latest Refusal
10/22/2015
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

837×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
10/22/2015
24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Division of West Coast Imports (DWCI)
10/22/2015
24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Division of West Coast Imports (DWCI)
10/22/2015
24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Division of West Coast Imports (DWCI)
10/22/2015
24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Division of West Coast Imports (DWCI)
10/22/2015
24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Division of West Coast Imports (DWCI)
10/22/2015
25ECI99MIXED VEGETABLES, N.E.C.
83NO PROCESS
Division of West Coast Imports (DWCI)
10/22/2015
25ECI07CUCUMBERS AND TOMATOES (MIXED VEGETABLES)
83NO PROCESS
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Aisis OOD's FDA import refusal history?

Aisis OOD (FEI: 3003293568) has 7 FDA import refusal record(s) in our database, spanning from 10/22/2015 to 10/22/2015.

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. Aisis OOD's FEI number is 3003293568.

What types of violations has Aisis OOD received?

Aisis OOD 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 Aisis OOD come from?

All FDA import refusal data for Aisis OOD 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.