Tinchikin Pharmaceutical Mfg Ltd
⚠️ Moderate Risk
FEI: 3003691292 • Kwun Tong, Kowloon • HONG KONG
FEI Number
3003691292
Location
Kwun Tong, Kowloon
Country
HONG KONGAddress
13/F, Tai Fung Industrial Building Block A, 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
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
HEALTH C
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 bears an unauthorized nutrient content/health claim.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
Frequently Asked Questions
What is Tinchikin Pharmaceutical Mfg Ltd's FDA import refusal history?
Tinchikin Pharmaceutical Mfg Ltd (FEI: 3003691292) has 2 FDA import refusal record(s) in our database, spanning from 12/24/2003 to 3/14/2005.
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. Tinchikin Pharmaceutical Mfg Ltd's FEI number is 3003691292.
What types of violations has Tinchikin Pharmaceutical Mfg Ltd received?
Tinchikin Pharmaceutical Mfg 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 Tinchikin Pharmaceutical Mfg Ltd come from?
All FDA import refusal data for Tinchikin Pharmaceutical Mfg 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.