ANTAI BIO-TECH CO.,LTD
⚠️ Moderate Risk
FEI: 3011329886 • Shanghai, Shanghai • CHINA
FEI Number
3011329886
Location
Shanghai, Shanghai
Country
CHINAAddress
Shanghai Room, 39 Chezhan South Rd, Shanghai, Shanghai, 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).
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.
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.
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2012 | 54FBH89TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 3721PESTICIDE2 | Southwest Import District Office (SWI-DO) |
| 1/31/2012 | 65ACS99MEMORY ADJUVANT, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 9/7/2011 | 65FCL99WATER N.E.C. (PHARMACEUTIC AID) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ANTAI BIO-TECH CO.,LTD's FDA import refusal history?
ANTAI BIO-TECH CO.,LTD (FEI: 3011329886) has 3 FDA import refusal record(s) in our database, spanning from 9/7/2011 to 5/22/2012.
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. ANTAI BIO-TECH CO.,LTD's FEI number is 3011329886.
What types of violations has ANTAI BIO-TECH CO.,LTD received?
ANTAI BIO-TECH CO.,LTD has been cited for 5 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 ANTAI BIO-TECH CO.,LTD come from?
All FDA import refusal data for ANTAI 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.