HI CARE THAI GLOVES COMPANY LTD
⚠️ Moderate Risk
FEI: 3016855992 • Hatyai, Songkhla • THAILAND
FEI Number
3016855992
Location
Hatyai, Songkhla
Country
THAILANDAddress
199 Moo 11, Tambon Banpru Amphur, , Hatyai, Songkhla, Thailand
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is HI CARE THAI GLOVES COMPANY LTD's FDA import refusal history?
HI CARE THAI GLOVES COMPANY LTD (FEI: 3016855992) has 2 FDA import refusal record(s) in our database, spanning from 11/22/2022 to 7/24/2024.
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. HI CARE THAI GLOVES COMPANY LTD's FEI number is 3016855992.
What types of violations has HI CARE THAI GLOVES COMPANY LTD received?
HI CARE THAI GLOVES COMPANY LTD has been cited for 3 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 HI CARE THAI GLOVES COMPANY LTD come from?
All FDA import refusal data for HI CARE THAI GLOVES COMPANY 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.