Changzhou Jialing Medicine Industry Co. Ltd.
⚠️ Moderate Risk
FEI: 3006257509 • Jiangsu • CHINA
FEI Number
3006257509
Location
Jiangsu
Country
CHINAAddress
Shui Bei Town Jin Tan City, , 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).
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 |
|---|---|---|---|
| 9/3/2013 | 65JCR31PROGESTERONE (PROGESTIN) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/15/2007 | 65JCZ31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/15/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/3/2007 | 64LCZ58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/3/2007 | 65JCZ31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Changzhou Jialing Medicine Industry Co. Ltd.'s FDA import refusal history?
Changzhou Jialing Medicine Industry Co. Ltd. (FEI: 3006257509) has 5 FDA import refusal record(s) in our database, spanning from 10/3/2007 to 9/3/2013.
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 Jialing Medicine Industry Co. Ltd.'s FEI number is 3006257509.
What types of violations has Changzhou Jialing Medicine Industry Co. Ltd. received?
Changzhou Jialing Medicine Industry 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 Changzhou Jialing Medicine Industry Co. Ltd. come from?
All FDA import refusal data for Changzhou Jialing Medicine Industry 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.