Chongqing Imperial Bio Chem Co
⚠️ Moderate Risk
FEI: 3004074796 • Jiangbei, Chongqing • CHINA
FEI Number
3004074796
Location
Jiangbei, Chongqing
Country
CHINAAddress
Citic Bank 19-7, 5 Yanghesancun, Jiangbei, Chongqing, 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
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2009 | 55RY75CRUDE HEPARIN (PHARMACEUTIC NECESSITY) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 5/18/2009 | 55RY75CRUDE HEPARIN (PHARMACEUTIC NECESSITY) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 3/10/2009 | 55RY75CRUDE HEPARIN (PHARMACEUTIC NECESSITY) | Cincinnati District Office (CIN-DO) | |
| 5/16/2005 | 75LZXACID, SODIUM HYALURONIC | 72NEW VET DR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Chongqing Imperial Bio Chem Co's FDA import refusal history?
Chongqing Imperial Bio Chem Co (FEI: 3004074796) has 4 FDA import refusal record(s) in our database, spanning from 5/16/2005 to 6/15/2009.
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. Chongqing Imperial Bio Chem Co's FEI number is 3004074796.
What types of violations has Chongqing Imperial Bio Chem Co received?
Chongqing Imperial Bio Chem Co 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 Chongqing Imperial Bio Chem Co come from?
All FDA import refusal data for Chongqing Imperial Bio Chem Co 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.