Shanghai Whitecat Shareholding Co., Ltd.
⚠️ Moderate Risk
FEI: 3003884046 • Shanghai, Shanghai • CHINA
FEI Number
3003884046
Location
Shanghai, Shanghai
Country
CHINAAddress
1829 Jinsha Jiang Road, , Shanghai, Shanghai, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/14/2007 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/14/2007 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/14/2007 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 10/15/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 10/15/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/7/2005 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Whitecat Shareholding Co., Ltd.'s FDA import refusal history?
Shanghai Whitecat Shareholding Co., Ltd. (FEI: 3003884046) has 14 FDA import refusal record(s) in our database, spanning from 1/7/2005 to 9/14/2007.
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. Shanghai Whitecat Shareholding Co., Ltd.'s FEI number is 3003884046.
What types of violations has Shanghai Whitecat Shareholding Co., Ltd. received?
Shanghai Whitecat Shareholding Co., Ltd. has been cited for 3 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 Shanghai Whitecat Shareholding Co., Ltd. come from?
All FDA import refusal data for Shanghai Whitecat Shareholding 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.