Contac
⚠️ High Risk
FEI: 3002832942 • Delta, British Columbia • CANADA
FEI Number
3002832942
Location
Delta, British Columbia
Country
CANADAAddress
6600 Dennett Pl, , Delta, British Columbia, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/20/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 1/20/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 1/13/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/10/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/30/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/27/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 12/27/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 56YCY99ANTIBIOTIC N.E.C. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 56YCY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/10/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/10/2011 | 56YCY99ANTIBIOTIC N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Contac's FDA import refusal history?
Contac (FEI: 3002832942) has 15 FDA import refusal record(s) in our database, spanning from 11/10/2011 to 1/20/2012.
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. Contac's FEI number is 3002832942.
What types of violations has Contac received?
Contac 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 Contac come from?
All FDA import refusal data for Contac 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.