Bio-Balance Remedies Inc.
⚠️ Moderate Risk
FEI: 3008990264 • Surreysurrey, BC • CANADA
FEI Number
3008990264
Location
Surreysurrey, BC
Country
CANADAAddress
#409 15940 Fraser Hwy, , Surreysurrey, BC, Canada
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
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2011 | 54FYA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 8/8/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Seattle District Office (SEA-DO) |
| 8/8/2011 | 53EA07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 8/8/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 8/8/2011 | 54FYA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Bio-Balance Remedies Inc.'s FDA import refusal history?
Bio-Balance Remedies Inc. (FEI: 3008990264) has 5 FDA import refusal record(s) in our database, spanning from 8/8/2011 to 8/8/2011.
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. Bio-Balance Remedies Inc.'s FEI number is 3008990264.
What types of violations has Bio-Balance Remedies Inc. received?
Bio-Balance Remedies Inc. 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 Bio-Balance Remedies Inc. come from?
All FDA import refusal data for Bio-Balance Remedies 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.