Nanjing White Whale Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003821347 • Nanjing, Jiangsu • CHINA
FEI Number
3003821347
Location
Nanjing, Jiangsu
Country
CHINAAddress
No. 29 Fangshuidonglu Road, Jiangbei New Area, Nanjing, 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
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.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2014 | 61WCS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 10/29/2013 | 61WLT47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 1/28/2011 | 75NDRIMMUNOASSAY, ENZYME, INHIBIN-A | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/3/2010 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nanjing White Whale Pharmaceutical Co., Ltd.'s FDA import refusal history?
Nanjing White Whale Pharmaceutical Co., Ltd. (FEI: 3003821347) has 4 FDA import refusal record(s) in our database, spanning from 3/3/2010 to 11/18/2014.
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. Nanjing White Whale Pharmaceutical Co., Ltd.'s FEI number is 3003821347.
What types of violations has Nanjing White Whale Pharmaceutical Co., Ltd. received?
Nanjing White Whale Pharmaceutical 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 Nanjing White Whale Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Nanjing White Whale Pharmaceutical 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.