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BAGS AND GLOVES CO., LTD.

⚠️ Moderate Risk

FEI: 3018313280 • Bangkok • THAILAND

FEI

FEI Number

3018313280

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

481/792 Charan Sanitwong Road, Soi Charan Sanitwong 37, Bangkok, , Thailand

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
2/27/2013
Latest Refusal
2/27/2013
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
2/27/2013
78FFYADAPTOR, BULBS, MISCELLANEOUS, FOR ENDOSCOPE
118NOT LISTED
New Orleans District Office (NOL-DO)
2/27/2013
78FFYADAPTOR, BULBS, MISCELLANEOUS, FOR ENDOSCOPE
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is BAGS AND GLOVES CO., LTD.'s FDA import refusal history?

BAGS AND GLOVES CO., LTD. (FEI: 3018313280) has 2 FDA import refusal record(s) in our database, spanning from 2/27/2013 to 2/27/2013.

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. BAGS AND GLOVES CO., LTD.'s FEI number is 3018313280.

What types of violations has BAGS AND GLOVES CO., LTD. received?

BAGS AND GLOVES CO., LTD. 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 BAGS AND GLOVES CO., LTD. come from?

All FDA import refusal data for BAGS AND GLOVES 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.