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MERKABA CORP. LTD.

⚠️ Moderate Risk

FEI: 3011771797 • Sofia, Sofia • BULGARIA

FEI

FEI Number

3011771797

📍

Location

Sofia, Sofia

🇧🇬

Country

BULGARIA
🏢

Address

Ul. Karlovo 6A, Ap. 10A, , Sofia, Sofia, Bulgaria

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/17/2017
Latest Refusal
1/17/2017
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
1/17/2017
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
2280DIRSEXMPT
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is MERKABA CORP. LTD.'s FDA import refusal history?

MERKABA CORP. LTD. (FEI: 3011771797) has 1 FDA import refusal record(s) in our database, spanning from 1/17/2017 to 1/17/2017.

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. MERKABA CORP. LTD.'s FEI number is 3011771797.

What types of violations has MERKABA CORP. LTD. received?

MERKABA CORP. LTD. 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 MERKABA CORP. LTD. come from?

All FDA import refusal data for MERKABA CORP. LTD. 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.