Ling Chi Medicine Co(Hk) Ltd
⚠️ Moderate Risk
FEI: 3005216869 • Chai Wan, Hong Kong Island • HONG KONG
FEI Number
3005216869
Location
Chai Wan, Hong Kong Island
Country
HONG KONGAddress
1/F, Summit Industrial Building; 9 Sun Yip Street, Chai Wan, Hong Kong Island, 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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2016 | 60LBL99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/19/2014 | 62MDY08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 11/9/2012 | 62GBL99ANTI-INFLAMMATORY N.E.C. | 223FALSE | New York District Office (NYK-DO) |
| 11/9/2012 | 62GBL99ANTI-INFLAMMATORY N.E.C. | 223FALSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ling Chi Medicine Co(Hk) Ltd's FDA import refusal history?
Ling Chi Medicine Co(Hk) Ltd (FEI: 3005216869) has 4 FDA import refusal record(s) in our database, spanning from 11/9/2012 to 5/4/2016.
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. Ling Chi Medicine Co(Hk) Ltd's FEI number is 3005216869.
What types of violations has Ling Chi Medicine Co(Hk) Ltd received?
Ling Chi Medicine Co(Hk) Ltd has been cited for 6 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 Ling Chi Medicine Co(Hk) Ltd come from?
All FDA import refusal data for Ling Chi Medicine Co(Hk) 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.