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POMA Group CO., Ltd.

✅ Low Risk

FEI: 3006320259 • Bangkok • THAILAND

FEI

FEI Number

3006320259

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

55/125-6 Ngarmwongwan Road, Donmueng, Bangkok, , Thailand

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
8/8/2007
Latest Refusal
8/8/2007
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4722×

NO ENGLISH

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

Refusal History

DateProductViolationsDivision
8/8/2007
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
Los Angeles District Office (LOS-DO)
8/8/2007
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is POMA Group CO., Ltd.'s FDA import refusal history?

POMA Group CO., Ltd. (FEI: 3006320259) has 2 FDA import refusal record(s) in our database, spanning from 8/8/2007 to 8/8/2007.

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. POMA Group CO., Ltd.'s FEI number is 3006320259.

What types of violations has POMA Group CO., Ltd. received?

POMA Group CO., 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 POMA Group CO., Ltd. come from?

All FDA import refusal data for POMA Group CO., 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.