Body Blue 2006, Inc.
⚠️ Moderate Risk
FEI: 3004933497 • Etobicoke, Ontario • CANADA
FEI Number
3004933497
Location
Etobicoke, Ontario
Country
CANADAAddress
130 Claireville Dr, , Etobicoke, Ontario, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2016 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 7/16/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/3/2008 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 223FALSE | New York District Office (NYK-DO) |
| 7/3/2008 | 62WAJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 6/25/2008 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/25/2008 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/5/2008 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 223FALSE | New York District Office (NYK-DO) |
| 5/5/2008 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 223FALSE | New York District Office (NYK-DO) |
| 4/8/2008 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 12/18/2006 | 62NAL99ANTI-PSORIATIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Body Blue 2006, Inc.'s FDA import refusal history?
Body Blue 2006, Inc. (FEI: 3004933497) has 10 FDA import refusal record(s) in our database, spanning from 12/18/2006 to 11/29/2016.
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. Body Blue 2006, Inc.'s FEI number is 3004933497.
What types of violations has Body Blue 2006, Inc. received?
Body Blue 2006, Inc. has been cited for 7 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 Body Blue 2006, Inc. come from?
All FDA import refusal data for Body Blue 2006, 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.