Viking Life-Saving Equipment (Thailand) Ltd.
✅ Low Risk
FEI: 3018514332 • Chonburi • THAILAND
FEI Number
3018514332
Location
Chonburi
Country
THAILANDAddress
Laem Chabang Industrial Estate, 38/21, 38/43, Moo 5 Tungsukhla, Chonburi, , Thailand
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 Viking Life-Saving Equipment (Thailand) Ltd.'s FDA import refusal history?
Viking Life-Saving Equipment (Thailand) Ltd. (FEI: 3018514332) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2021 to 5/17/2021.
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. Viking Life-Saving Equipment (Thailand) Ltd.'s FEI number is 3018514332.
What types of violations has Viking Life-Saving Equipment (Thailand) Ltd. received?
Viking Life-Saving Equipment (Thailand) Ltd. has been cited for 4 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 Viking Life-Saving Equipment (Thailand) Ltd. come from?
All FDA import refusal data for Viking Life-Saving Equipment (Thailand) 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.