Chan Yat Hing Medicine Factory
⚠️ Moderate Risk
FEI: 3005440817 • Mong Kok, Kowloon • HONG KONG
FEI Number
3005440817
Location
Mong Kok, Kowloon
Country
HONG KONGAddress
Flat 3, 9/F, Fuk Keung Industrial Bldg.; 66-68 Tong Mei Road, Mong Kok, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2023 | 60LBL99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/27/2016 | 60LBJ07CAMPHORATED OIL | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/27/2016 | 60LBJ07CAMPHORATED OIL | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/9/2013 | 60LAJ63SALICYLAMIDE (ANALGESIC) | Los Angeles District Office (LOS-DO) | |
| 12/9/2013 | 60LAJ63SALICYLAMIDE (ANALGESIC) | Los Angeles District Office (LOS-DO) | |
| 12/9/2013 | 60LAJ63SALICYLAMIDE (ANALGESIC) | Los Angeles District Office (LOS-DO) | |
| 8/13/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/16/2012 | 62MBL08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 8/12/2010 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/15/2008 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 4/15/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New York District Office (NYK-DO) |
| 4/15/2008 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/15/2008 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/15/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Chan Yat Hing Medicine Factory's FDA import refusal history?
Chan Yat Hing Medicine Factory (FEI: 3005440817) has 14 FDA import refusal record(s) in our database, spanning from 4/15/2008 to 9/19/2023.
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. Chan Yat Hing Medicine Factory's FEI number is 3005440817.
What types of violations has Chan Yat Hing Medicine Factory received?
Chan Yat Hing Medicine Factory 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 Chan Yat Hing Medicine Factory come from?
All FDA import refusal data for Chan Yat Hing Medicine Factory 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.