Blue Wings
⚠️ High Risk
FEI: 3025604892 • Kwai Chung, Hong Kong • HONG KONG
FEI Number
3025604892
Location
Kwai Chung, Hong Kong
Country
HONG KONGAddress
Rm C1 11/F Blk 1, , Kwai Chung, Hong Kong, Hong Kong
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 4/11/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 4/11/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 4/11/2023 | 65QDR02BOTOX | Division of Southeast Imports (DSEI) | |
| 4/11/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 4/11/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 4/11/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 3/27/2023 | 65QDR02BOTOX | Division of Southeast Imports (DSEI) | |
| 3/27/2023 | 60QCY07LIDOCAINE | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/8/2023 | 65QCY02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 65QDR02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 65QDR02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 65QDR02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 65QDR02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 65QDR02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 65QCY02BOTOX | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 60QDL99ANESTHETIC, N.E.C. | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 3/8/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of West Coast Imports (DWCI) | |
| 3/8/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of West Coast Imports (DWCI) | |
| 3/7/2023 | 65QDR02BOTOX | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Blue Wings's FDA import refusal history?
Blue Wings (FEI: 3025604892) has 24 FDA import refusal record(s) in our database, spanning from 3/7/2023 to 4/11/2023.
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. Blue Wings's FEI number is 3025604892.
What types of violations has Blue Wings received?
Blue Wings has been cited for 8 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 Blue Wings come from?
All FDA import refusal data for Blue Wings 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.