Changchun GeneScience Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004699325 • Changchun City, Jilin • CHINA
FEI Number
3004699325
Location
Changchun City, Jilin
Country
CHINAAddress
No. 72 Tianhe Street, Changchun High-Tech Dev. Zone, Changchun City, Jilin, 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2010 | 64RBY22SOMATROPIN (RDNA ORIGIN) (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 12/19/2007 | 64RCP18HUMAN GROWTH HORMONE (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/19/2007 | 64RCP18HUMAN GROWTH HORMONE (HORMONE) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/19/2007 | 64RCB21SOMATROPIN (HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/16/2005 | 64RCK18HUMAN GROWTH HORMONE (HORMONE) | Los Angeles District Office (LOS-DO) | |
| 7/14/2004 | 64RBK18HUMAN GROWTH HORMONE (HORMONE) | San Francisco District Office (SAN-DO) | |
| 9/3/2003 | 64RAK18HUMAN GROWTH HORMONE (HORMONE) | San Francisco District Office (SAN-DO) | |
| 7/10/2003 | 64RCK22SOMATROPIN (RDNA ORIGIN) (HORMONE) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Changchun GeneScience Pharmaceutical Co., Ltd.'s FDA import refusal history?
Changchun GeneScience Pharmaceutical Co., Ltd. (FEI: 3004699325) has 8 FDA import refusal record(s) in our database, spanning from 7/10/2003 to 11/29/2010.
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. Changchun GeneScience Pharmaceutical Co., Ltd.'s FEI number is 3004699325.
What types of violations has Changchun GeneScience Pharmaceutical Co., Ltd. received?
Changchun GeneScience Pharmaceutical Co., Ltd. has been cited for 6 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 Changchun GeneScience Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Changchun GeneScience 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.