Yick-Vic Chemicals & Pharmaceuticals (HK) LTD
⚠️ Moderate Risk
FEI: 3003494606 • Kwun Tong, Kowloon • HONG KONG
FEI Number
3003494606
Location
Kwun Tong, Kowloon
Country
HONG KONGAddress
10/F, 1006/Room, Hewlett Centre; No. 52-54 Hoi Yuen Road, Kwun Tong, 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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2015 | 61MSY25PRIMIDONE (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 9/8/2008 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 9/25/2007 | 64UCS03CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 2/6/2006 | 64RCS21SOMATROPIN (HORMONE) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/14/2005 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/3/2004 | 60XCS04PHENTOLAMINE MESYLATE (ANTI-ADRENERGIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/5/2004 | 64BCS37SPIRONOLACTONE (DIURETIC) | New York District Office (NYK-DO) | |
| 4/9/2004 | 66KCS99THYROID INHIBITOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/9/2003 | 56EAS22DOXYCYCLINE HYCLATE (TETRACYCLINES) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Yick-Vic Chemicals & Pharmaceuticals (HK) LTD's FDA import refusal history?
Yick-Vic Chemicals & Pharmaceuticals (HK) LTD (FEI: 3003494606) has 9 FDA import refusal record(s) in our database, spanning from 10/9/2003 to 9/22/2015.
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. Yick-Vic Chemicals & Pharmaceuticals (HK) LTD's FEI number is 3003494606.
What types of violations has Yick-Vic Chemicals & Pharmaceuticals (HK) LTD received?
Yick-Vic Chemicals & Pharmaceuticals (HK) 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 Yick-Vic Chemicals & Pharmaceuticals (HK) LTD come from?
All FDA import refusal data for Yick-Vic Chemicals & Pharmaceuticals (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.