Wong To Yick Wood Lock Ointment Limited
⚠️ Moderate Risk
FEI: 3003613970 • Kwai Chung, New Territories • HONG KONG
FEI Number
3003613970
Location
Kwai Chung, New Territories
Country
HONG KONGAddress
4/F, Mai Shun Industrial Building; 18-24 Kwai Cheong Road, Kwai Chung, New Territories, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 |
|---|---|---|---|
| 12/24/2015 | 55PY97METHYL SALICYLATE (PHARMACEUTIC NECESSITY - FLAVOR) | 472NO ENGLISH | Cincinnati District Office (CIN-DO) |
| 3/7/2013 | 62MBL01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 1/22/2008 | 60LBJ99ANALGESIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Wong To Yick Wood Lock Ointment Limited's FDA import refusal history?
Wong To Yick Wood Lock Ointment Limited (FEI: 3003613970) has 3 FDA import refusal record(s) in our database, spanning from 1/22/2008 to 12/24/2015.
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. Wong To Yick Wood Lock Ointment Limited's FEI number is 3003613970.
What types of violations has Wong To Yick Wood Lock Ointment Limited received?
Wong To Yick Wood Lock Ointment Limited 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 Wong To Yick Wood Lock Ointment Limited come from?
All FDA import refusal data for Wong To Yick Wood Lock Ointment 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.