EASYSHIP FULFILLMENT SERVICES LTD
⚠️ Moderate Risk
FEI: 3015226378 • Hong Kong • HONG KONG
FEI Number
3015226378
Location
Hong Kong
Country
HONG KONGAddress
Unit 4-6, 2/F, Lee Wahmansion, Hong Kong, , 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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.
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 |
|---|---|---|---|
| 4/12/2019 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 4/12/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/12/2019 | 60QCY07LIDOCAINE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EASYSHIP FULFILLMENT SERVICES LTD's FDA import refusal history?
EASYSHIP FULFILLMENT SERVICES LTD (FEI: 3015226378) has 3 FDA import refusal record(s) in our database, spanning from 4/12/2019 to 4/12/2019.
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. EASYSHIP FULFILLMENT SERVICES LTD's FEI number is 3015226378.
What types of violations has EASYSHIP FULFILLMENT SERVICES LTD received?
EASYSHIP FULFILLMENT SERVICES LTD has been cited for 5 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 EASYSHIP FULFILLMENT SERVICES LTD come from?
All FDA import refusal data for EASYSHIP FULFILLMENT SERVICES 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.