Strategic Manufacturing Co., Ltd.
⚠️ Moderate Risk
FEI: 3007012468 • Klongluang • THAILAND
FEI Number
3007012468
Location
Klongluang
Country
THAILANDAddress
16-17 Moo 18, Paholyothin Rd.,, , Klongluang, , 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
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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 Strategic Manufacturing Co., Ltd.'s FDA import refusal history?
Strategic Manufacturing Co., Ltd. (FEI: 3007012468) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2008 to 12/2/2008.
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. Strategic Manufacturing Co., Ltd.'s FEI number is 3007012468.
What types of violations has Strategic Manufacturing Co., Ltd. received?
Strategic Manufacturing 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 Strategic Manufacturing Co., Ltd. come from?
All FDA import refusal data for Strategic Manufacturing 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.