China National Chemical Construction Dalian Co.
⚠️ Moderate Risk
FEI: 3000193788 • Dalian City, Liaoningsheng • CHINA
FEI Number
3000193788
Location
Dalian City, Liaoningsheng
Country
CHINAAddress
14 Baishanlu, , Dalian City, Liaoningsheng, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2009 | 60TAS05CIMETIDINE (ANTAGONIST) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2009 | 60TAS05CIMETIDINE (ANTAGONIST) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2009 | 56KCR70RIFAMPIN | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2009 | 56KCR70RIFAMPIN | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2009 | 56KCR70RIFAMPIN | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2009 | 56KCR70RIFAMPIN | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2009 | 54ADS15VITAMIN D2 (CALCIFEROL) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/10/2003 | 64GCS13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is China National Chemical Construction Dalian Co.'s FDA import refusal history?
China National Chemical Construction Dalian Co. (FEI: 3000193788) has 8 FDA import refusal record(s) in our database, spanning from 7/10/2003 to 9/22/2009.
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. China National Chemical Construction Dalian Co.'s FEI number is 3000193788.
What types of violations has China National Chemical Construction Dalian Co. received?
China National Chemical Construction Dalian Co. 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 China National Chemical Construction Dalian Co. come from?
All FDA import refusal data for China National Chemical Construction Dalian 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.