Suzhou Vitajoy Bio-Tech Co., LTD.
⚠️ Moderate Risk
FEI: 3010432832 • Suzhou, Jiangsusheng • CHINA
FEI Number
3010432832
Location
Suzhou, Jiangsusheng
Country
CHINAAddress
1501-1502,No.19,Guangji South Road, , Suzhou, Jiangsusheng, 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
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).
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.
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2016 | 54FBR12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 241PESTICIDE | Los Angeles District Office (LOS-DO) |
| 10/14/2016 | 54FBR12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 241PESTICIDE | Los Angeles District Office (LOS-DO) |
| 6/16/2016 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 7/29/2015 | 54YER99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/28/2015 | 54YER99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/5/2015 | 65JCR31PROGESTERONE (PROGESTIN) | Los Angeles District Office (LOS-DO) | |
| 12/17/2014 | 54YER99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Suzhou Vitajoy Bio-Tech Co., LTD.'s FDA import refusal history?
Suzhou Vitajoy Bio-Tech Co., LTD. (FEI: 3010432832) has 7 FDA import refusal record(s) in our database, spanning from 12/17/2014 to 10/14/2016.
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. Suzhou Vitajoy Bio-Tech Co., LTD.'s FEI number is 3010432832.
What types of violations has Suzhou Vitajoy Bio-Tech Co., LTD. received?
Suzhou Vitajoy Bio-Tech Co., LTD. has been cited for 6 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 Suzhou Vitajoy Bio-Tech Co., LTD. come from?
All FDA import refusal data for Suzhou Vitajoy Bio-Tech 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.