Hongze Chenguang Fine Cchemical Co. Ltd.
⚠️ Moderate Risk
FEI: 3005095227 • Hiingze • CHINA
FEI Number
3005095227
Location
Hiingze
Country
CHINAAddress
Chemical Circle, Indust. Park, , Hiingze, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/31/2007 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 12/31/2007 | 66VCZ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 12/31/2007 | 66VOR99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/27/2007 | 65AAR99MEMORY ADJUVANT, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hongze Chenguang Fine Cchemical Co. Ltd.'s FDA import refusal history?
Hongze Chenguang Fine Cchemical Co. Ltd. (FEI: 3005095227) has 4 FDA import refusal record(s) in our database, spanning from 12/27/2007 to 12/31/2007.
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. Hongze Chenguang Fine Cchemical Co. Ltd.'s FEI number is 3005095227.
What types of violations has Hongze Chenguang Fine Cchemical Co. Ltd. received?
Hongze Chenguang Fine Cchemical Co. Ltd. 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 Hongze Chenguang Fine Cchemical Co. Ltd. come from?
All FDA import refusal data for Hongze Chenguang Fine Cchemical 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.