Amata Medicare Co., Ltd.
⚠️ Moderate Risk
FEI: 3013735127 • Muang Nonthaburi, Nonthaburi • THAILAND
FEI Number
3013735127
Location
Muang Nonthaburi, Nonthaburi
Country
THAILANDAddress
117/14, 117/33, Moo 5; Bangphai, Muang Nonthaburi, Nonthaburi, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/27/2023 | 80FMFSYRINGE, PISTON | 126FAILS STD | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Amata Medicare Co., Ltd.'s FDA import refusal history?
Amata Medicare Co., Ltd. (FEI: 3013735127) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2023 to 1/27/2023.
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. Amata Medicare Co., Ltd.'s FEI number is 3013735127.
What types of violations has Amata Medicare Co., Ltd. received?
Amata Medicare 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 Amata Medicare Co., Ltd. come from?
All FDA import refusal data for Amata Medicare 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.