Acetar Bio-Tech Inc.
⚠️ Moderate Risk
FEI: 3006765340 • Xian, Shanxi • CHINA
FEI Number
3006765340
Location
Xian, Shanxi
Country
CHINAAddress
No. 2 Jicai South Road, Jixian Industry Zone, Zhouzhi County, Xian, Shanxi, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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:
SACCHARLBL
The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2014 | 22HGH99OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C. | New York District Office (NYK-DO) | |
| 7/11/2013 | 54FBR08ECHINACEA, HERBAL & BOTANICALS (NOT TEAS) | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 3/8/2012 | 60D99ADRENOCORTICAL STEROID N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Acetar Bio-Tech Inc.'s FDA import refusal history?
Acetar Bio-Tech Inc. (FEI: 3006765340) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2012 to 7/15/2014.
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. Acetar Bio-Tech Inc.'s FEI number is 3006765340.
What types of violations has Acetar Bio-Tech Inc. received?
Acetar Bio-Tech Inc. 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 Acetar Bio-Tech Inc. come from?
All FDA import refusal data for Acetar Bio-Tech Inc. 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.