Taizhou Kanglin Health Protection Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3005676766 • Taizhou, Jiangsu • CHINA
FEI Number
3005676766
Location
Taizhou, Jiangsu
Country
CHINAAddress
The West Of Qiliqiao, Hailing District, Taizhou, Jiangsu, China
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
HELD INSAN
The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2012 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/2/2012 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Division of Northeast Imports (DNEI) |
| 3/2/2012 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Division of Northeast Imports (DNEI) |
| 3/2/2012 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 78STERILITY | Division of Northeast Imports (DNEI) |
| 3/2/2012 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 78STERILITY | Division of Northeast Imports (DNEI) |
| 12/21/2011 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 310POISONOUS | New York District Office (NYK-DO) |
| 6/18/2007 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Taizhou Kanglin Health Protection Products Co., Ltd.'s FDA import refusal history?
Taizhou Kanglin Health Protection Products Co., Ltd. (FEI: 3005676766) has 7 FDA import refusal record(s) in our database, spanning from 6/18/2007 to 4/20/2012.
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. Taizhou Kanglin Health Protection Products Co., Ltd.'s FEI number is 3005676766.
What types of violations has Taizhou Kanglin Health Protection Products Co., Ltd. received?
Taizhou Kanglin Health Protection Products Co., 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 Taizhou Kanglin Health Protection Products Co., Ltd. come from?
All FDA import refusal data for Taizhou Kanglin Health Protection Products Co., 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.