MAZUT INTERNATIONAL HK LIMITED
⚠️ Moderate Risk
FEI: 3014663324 • Sham Shui Po, Kowloon • HONG KONG
FEI Number
3014663324
Location
Sham Shui Po, Kowloon
Country
HONG KONGAddress
G F. 49-51 Jerviioius Str, 13 Shek Kip Mei Street, Sham Shui Po, Kowloon, 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.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2021 | 83QLTCOVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/2/2021 | 88LNJANALYZER, CHROMOSOME, AUTOMATED | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/26/2021 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 8/17/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MAZUT INTERNATIONAL HK LIMITED's FDA import refusal history?
MAZUT INTERNATIONAL HK LIMITED (FEI: 3014663324) has 4 FDA import refusal record(s) in our database, spanning from 8/17/2020 to 6/29/2021.
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. MAZUT INTERNATIONAL HK LIMITED's FEI number is 3014663324.
What types of violations has MAZUT INTERNATIONAL HK LIMITED received?
MAZUT INTERNATIONAL HK LIMITED 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 MAZUT INTERNATIONAL HK LIMITED come from?
All FDA import refusal data for MAZUT INTERNATIONAL HK 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.