Nutriworks Limited
⚠️ Moderate Risk
FEI: 3003972597 • Tsim Sha Tsui, Kowloon • HONG KONG
FEI Number
3003972597
Location
Tsim Sha Tsui, Kowloon
Country
HONG KONGAddress
Unit 501, Swire & Maclaine House; 19-23 Austin Avenue, Tsim Sha Tsui, 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
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 4/9/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | New York District Office (NYK-DO) | |
| 12/16/2005 | 79NBBPAD, PAIN | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/24/2003 | 79MXETAPE AND BANDAGE, ADHESIVE (WITH DISINFECTANT) | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 12/10/2002 | 60LBZ99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Nutriworks Limited's FDA import refusal history?
Nutriworks Limited (FEI: 3003972597) has 4 FDA import refusal record(s) in our database, spanning from 12/10/2002 to 4/9/2009.
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. Nutriworks Limited's FEI number is 3003972597.
What types of violations has Nutriworks Limited received?
Nutriworks 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 Nutriworks Limited come from?
All FDA import refusal data for Nutriworks 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.