Ingrid Millet Limited
⚠️ Moderate Risk
FEI: 3004118933 • Sheung Wan, Hong Kong Island • HONG KONG
FEI Number
3004118933
Location
Sheung Wan, Hong Kong Island
Country
HONG KONGAddress
Casey Building, 38 Lok Ku Road, Sheung Wan, Hong Kong Island, Hong Kong
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Ingrid Millet Limited's FDA import refusal history?
Ingrid Millet Limited (FEI: 3004118933) has 1 FDA import refusal record(s) in our database, spanning from 5/7/2020 to 5/7/2020.
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. Ingrid Millet Limited's FEI number is 3004118933.
What types of violations has Ingrid Millet Limited received?
Ingrid Millet Limited 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 Ingrid Millet Limited come from?
All FDA import refusal data for Ingrid Millet Limited 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.