Laboratoires Bio Botanical, Inc.
⚠️ Moderate Risk
FEI: 3003691699 • Baie-d'Urfe, Quebec • CANADA
FEI Number
3003691699
Location
Baie-d'Urfe, Quebec
Country
CANADAAddress
22200 Aut Transcanadienne, , Baie-d'Urfe, Quebec, 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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2011 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 310POISONOUS | New York District Office (NYK-DO) |
| 8/16/2011 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New York District Office (NYK-DO) |
| 4/7/2011 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 4/7/2011 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 3/16/2011 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 310POISONOUS | New York District Office (NYK-DO) |
| 11/30/2010 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 9/23/2010 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 7/23/2010 | 64AAL20TRICLOSAN (DISINFECTANT) | 16DIRECTIONS | New England District Office (NWE-DO) |
| 4/27/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New England District Office (NWE-DO) | |
| 4/27/2010 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 3/2/2010 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 3/2/2010 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 310POISONOUS | New England District Office (NWE-DO) |
| 4/11/2005 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/11/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 310POISONOUS | New York District Office (NYK-DO) |
| 8/26/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 310POISONOUS | New York District Office (NYK-DO) |
| 8/26/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/5/2003 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/5/2003 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/5/2003 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/16/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 310POISONOUS | New York District Office (NYK-DO) |
| 8/12/2002 | 03HYT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 473LABELING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratoires Bio Botanical, Inc.'s FDA import refusal history?
Laboratoires Bio Botanical, Inc. (FEI: 3003691699) has 21 FDA import refusal record(s) in our database, spanning from 8/12/2002 to 8/16/2011.
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. Laboratoires Bio Botanical, Inc.'s FEI number is 3003691699.
What types of violations has Laboratoires Bio Botanical, Inc. received?
Laboratoires Bio Botanical, 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 Laboratoires Bio Botanical, Inc. come from?
All FDA import refusal data for Laboratoires Bio Botanical, 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.