GUANGDONG HANYAN ACTIVATED CARBO
⚠️ Moderate Risk
FEI: 3012827013 • Guangzhou, Guangdong • CHINA
FEI Number
3012827013
Location
Guangzhou, Guangdong
Country
CHINAAddress
Xingnan Road, 674 Nancun, Guangzhou, Guangdong, 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/10/2018 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/10/2018 | 62FBR17HYDROGEN PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 10/31/2017 | 63RAR06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGDONG HANYAN ACTIVATED CARBO's FDA import refusal history?
GUANGDONG HANYAN ACTIVATED CARBO (FEI: 3012827013) has 3 FDA import refusal record(s) in our database, spanning from 10/31/2017 to 5/10/2018.
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. GUANGDONG HANYAN ACTIVATED CARBO's FEI number is 3012827013.
What types of violations has GUANGDONG HANYAN ACTIVATED CARBO received?
GUANGDONG HANYAN ACTIVATED CARBO has been cited for 4 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 GUANGDONG HANYAN ACTIVATED CARBO come from?
All FDA import refusal data for GUANGDONG HANYAN ACTIVATED CARBO 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.