ImportRefusal LogoImportRefusal

Ms Chuluuntsetseg

⚠️ Moderate Risk

FEI: 3005457940 • Ulaanbaatarulaanbaatar • MONGOLIA

FEI

FEI Number

3005457940

📍

Location

Ulaanbaatarulaanbaatar

🇲🇳

Country

MONGOLIA
🏢

Address

Songino Khairkhan Dist16th Khoroo Apt#26, , Ulaanbaatarulaanbaatar, , Mongolia

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
12/27/2005
Latest Refusal
12/27/2005
Earliest Refusal

Score Breakdown

Violation Severity
57.3×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

4726×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

755×

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
12/27/2005
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/27/2005
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/27/2005
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/27/2005
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/27/2005
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/27/2005
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ms Chuluuntsetseg's FDA import refusal history?

Ms Chuluuntsetseg (FEI: 3005457940) has 6 FDA import refusal record(s) in our database, spanning from 12/27/2005 to 12/27/2005.

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. Ms Chuluuntsetseg's FEI number is 3005457940.

What types of violations has Ms Chuluuntsetseg received?

Ms Chuluuntsetseg 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 Ms Chuluuntsetseg come from?

All FDA import refusal data for Ms Chuluuntsetseg 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.