Ameritek Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3005214988 • Guangzhou, Guangdong • CHINA
FEI Number
3005214988
Location
Guangzhou, Guangdong
Country
CHINAAddress
Suite 1803, No 7 Jintian North Street, Guangzhou, Guangdong, China
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2006 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 2/8/2006 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 2/8/2006 | 80FLESTERILIZER, STEAM | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ameritek Industrial Co., Ltd.'s FDA import refusal history?
Ameritek Industrial Co., Ltd. (FEI: 3005214988) has 3 FDA import refusal record(s) in our database, spanning from 2/8/2006 to 2/8/2006.
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. Ameritek Industrial Co., Ltd.'s FEI number is 3005214988.
What types of violations has Ameritek Industrial Co., Ltd. received?
Ameritek Industrial 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 Ameritek Industrial Co., Ltd. come from?
All FDA import refusal data for Ameritek Industrial 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.