Guangdong Classic Health-Care Products Co. Ltd.
⚠️ Moderate Risk
FEI: 3010478009 • Heyuan, Guangzhou • CHINA
FEI Number
3010478009
Location
Heyuan, Guangzhou
Country
CHINAAddress
XingJiang 3rd Road, , Heyuan, Guangzhou, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 8/20/2014 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/3/2014 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) | |
| 2/3/2014 | 54ACA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Guangdong Classic Health-Care Products Co. Ltd.'s FDA import refusal history?
Guangdong Classic Health-Care Products Co. Ltd. (FEI: 3010478009) has 3 FDA import refusal record(s) in our database, spanning from 2/3/2014 to 8/20/2014.
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 Classic Health-Care Products Co. Ltd.'s FEI number is 3010478009.
What types of violations has Guangdong Classic Health-Care Products Co. Ltd. received?
Guangdong Classic Health-Care Products Co. Ltd. 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 Classic Health-Care Products Co. Ltd. come from?
All FDA import refusal data for Guangdong Classic Health-Care Products 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.