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BAYKAL MAKINE SAN.VE TIC.A.S.

⚠️ Moderate Risk

FEI: 3015923498 • Bursa • TURKEY

FEI

FEI Number

3015923498

📍

Location

Bursa

🇹🇷

Country

TURKEY
🏢

Address

O.S.B.Yesil Cad.No:24, , Bursa, , Turkey

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/10/2019
Latest Refusal
12/10/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

471×

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

DateProductViolationsDivision
12/10/2019
95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
47NON STD
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is BAYKAL MAKINE SAN.VE TIC.A.S.'s FDA import refusal history?

BAYKAL MAKINE SAN.VE TIC.A.S. (FEI: 3015923498) has 1 FDA import refusal record(s) in our database, spanning from 12/10/2019 to 12/10/2019.

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. BAYKAL MAKINE SAN.VE TIC.A.S.'s FEI number is 3015923498.

What types of violations has BAYKAL MAKINE SAN.VE TIC.A.S. received?

BAYKAL MAKINE SAN.VE TIC.A.S. 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 BAYKAL MAKINE SAN.VE TIC.A.S. come from?

All FDA import refusal data for BAYKAL MAKINE SAN.VE TIC.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.