FUXION BIOTECH S.A.C.
⚠️ Moderate Risk
FEI: 3013123416 • Lima • PERU
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.
DIETARYING
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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3862DIETARYING | Division of Southwest Imports (DSWI) |
| 6/25/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/25/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/25/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/25/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/25/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Southwest Imports (DSWI) |
| 6/11/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is FUXION BIOTECH S.A.C.'s FDA import refusal history?
FUXION BIOTECH S.A.C. (FEI: 3013123416) has 20 FDA import refusal record(s) in our database, spanning from 6/11/2019 to 6/25/2019.
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. FUXION BIOTECH S.A.C.'s FEI number is 3013123416.
What types of violations has FUXION BIOTECH S.A.C. received?
FUXION BIOTECH S.A.C. has been cited for 3 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 FUXION BIOTECH S.A.C. come from?
All FDA import refusal data for FUXION BIOTECH S.A.C. 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.