Changzhou Jiangnan Ornamental Cloth Mill
⚠️ Moderate Risk
FEI: 1000601605 • Changzhou, Jiangsu • CHINA
FEI Number
1000601605
Location
Changzhou, Jiangsu
Country
CHINAAddress
Chang Zhou,Jiang Su,China, Beigangjiedao Beigangcun Wei Beigangzhen, Changzhou, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/14/2009 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/2/2008 | 65JAS31PROGESTERONE (PROGESTIN) | New York District Office (NYK-DO) | |
| 11/27/2007 | 64RSY99HORMONE N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/31/2007 | 65JCS31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/20/2007 | 65JAR31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/15/2007 | 65JIR31PROGESTERONE (PROGESTIN) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/17/2006 | 60NCS14TESTOSTERONE (ANDROGEN) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/26/2005 | 65JAR31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/26/2005 | 64RAR99HORMONE N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/17/2005 | 65JIS31PROGESTERONE (PROGESTIN) | San Francisco District Office (SAN-DO) | |
| 9/1/2004 | 60NCR99ANDROGEN, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Changzhou Jiangnan Ornamental Cloth Mill's FDA import refusal history?
Changzhou Jiangnan Ornamental Cloth Mill (FEI: 1000601605) has 11 FDA import refusal record(s) in our database, spanning from 9/1/2004 to 7/14/2009.
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. Changzhou Jiangnan Ornamental Cloth Mill's FEI number is 1000601605.
What types of violations has Changzhou Jiangnan Ornamental Cloth Mill received?
Changzhou Jiangnan Ornamental Cloth Mill 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 Changzhou Jiangnan Ornamental Cloth Mill come from?
All FDA import refusal data for Changzhou Jiangnan Ornamental Cloth Mill 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.