Nanjing Hichoice Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3003840565 • Nanjing, Jiangsu • CHINA
FEI Number
3003840565
Location
Nanjing, Jiangsu
Country
CHINAAddress
137 Wangfudajie, Baixia, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2007 | 64RCS21SOMATROPIN (HORMONE) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 3/20/2007 | 64RCS21SOMATROPIN (HORMONE) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 3/20/2007 | 64RCS21SOMATROPIN (HORMONE) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 3/20/2007 | 64RCS21SOMATROPIN (HORMONE) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 2/8/2006 | 64RCS21SOMATROPIN (HORMONE) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/15/2005 | 64RCS21SOMATROPIN (HORMONE) | Atlanta District Office (ATL-DO) | |
| 11/15/2005 | 64RCS21SOMATROPIN (HORMONE) | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Nanjing Hichoice Industrial Co., Ltd.'s FDA import refusal history?
Nanjing Hichoice Industrial Co., Ltd. (FEI: 3003840565) has 7 FDA import refusal record(s) in our database, spanning from 11/15/2005 to 3/20/2007.
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. Nanjing Hichoice Industrial Co., Ltd.'s FEI number is 3003840565.
What types of violations has Nanjing Hichoice Industrial Co., Ltd. received?
Nanjing Hichoice Industrial Co., Ltd. has been cited for 2 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 Hichoice Industrial Co., Ltd. come from?
All FDA import refusal data for Nanjing Hichoice Industrial 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.