HUIZHOU YINGGUANG PLASTIC PIGMEN
⚠️ Moderate Risk
FEI: 3014427755 • Huizhou • CHINA
FEI Number
3014427755
Location
Huizhou
Country
CHINAAddress
Bldg D2 F, Xinmeirui Ind, Huizhou, , 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
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2018 | 64RCZ18HUMAN GROWTH HORMONE (HORMONE) | Division of Southeast Imports (DSEI) | |
| 9/6/2018 | 64RCP18HUMAN GROWTH HORMONE (HORMONE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HUIZHOU YINGGUANG PLASTIC PIGMEN's FDA import refusal history?
HUIZHOU YINGGUANG PLASTIC PIGMEN (FEI: 3014427755) has 2 FDA import refusal record(s) in our database, spanning from 9/6/2018 to 9/6/2018.
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. HUIZHOU YINGGUANG PLASTIC PIGMEN's FEI number is 3014427755.
What types of violations has HUIZHOU YINGGUANG PLASTIC PIGMEN received?
HUIZHOU YINGGUANG PLASTIC PIGMEN has been cited for 7 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 HUIZHOU YINGGUANG PLASTIC PIGMEN come from?
All FDA import refusal data for HUIZHOU YINGGUANG PLASTIC PIGMEN 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.