Global Hotel Necessities Co., Ltd.
⚠️ Moderate Risk
FEI: 3004553413 • Nanhai District Guangdong • CHINA
FEI Number
3004553413
Location
Nanhai District Guangdong
Country
CHINAAddress
Zhennan Industrial Area,, Jiujiang Town, Nanhai District 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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 |
|---|---|---|---|
| 11/6/2019 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 1/10/2008 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Global Hotel Necessities Co., Ltd.'s FDA import refusal history?
Global Hotel Necessities Co., Ltd. (FEI: 3004553413) has 3 FDA import refusal record(s) in our database, spanning from 1/10/2008 to 11/6/2019.
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. Global Hotel Necessities Co., Ltd.'s FEI number is 3004553413.
What types of violations has Global Hotel Necessities Co., Ltd. received?
Global Hotel Necessities Co., Ltd. has been cited for 3 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 Global Hotel Necessities Co., Ltd. come from?
All FDA import refusal data for Global Hotel Necessities 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.