Nin Jiom Medicine Manufactory (HK) Ltd.
⚠️ Moderate Risk
FEI: 3000191892 • Tsuen Wan, New Territories • HONG KONG
FEI Number
3000191892
Location
Tsuen Wan, New Territories
Country
HONG KONGAddress
16/F, A Texaco Road Industrial Centre Block A; 256 Texaco Road, Tsuen Wan, 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
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).
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2014 | 33YEE99CANDY WITHOUT CHOCOLATE N.E.C. | New York District Office (NYK-DO) | |
| 8/6/2013 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/6/2013 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/14/2006 | 62UCL99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/13/2006 | 66FAL99SUPPRESSANT N.E.C. | New York District Office (NYK-DO) | |
| 6/19/2006 | 63SAL99DENTAL PROTECTANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/19/2006 | 63SAL99DENTAL PROTECTANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nin Jiom Medicine Manufactory (HK) Ltd.'s FDA import refusal history?
Nin Jiom Medicine Manufactory (HK) Ltd. (FEI: 3000191892) has 7 FDA import refusal record(s) in our database, spanning from 6/19/2006 to 3/18/2014.
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. Nin Jiom Medicine Manufactory (HK) Ltd.'s FEI number is 3000191892.
What types of violations has Nin Jiom Medicine Manufactory (HK) Ltd. received?
Nin Jiom Medicine Manufactory (HK) Ltd. has been cited for 4 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 Nin Jiom Medicine Manufactory (HK) Ltd. come from?
All FDA import refusal data for Nin Jiom Medicine Manufactory (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.