Dectro International, Inc.
⚠️ Moderate Risk
FEI: 3001446810 • Quebec, Quebec • CANADA
FEI Number
3001446810
Location
Quebec, Quebec
Country
CANADAAddress
1000 Du Parc-Technologique Blvd, , Quebec, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2020 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 2/22/2018 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/3/2015 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 2/11/2015 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | New England District Office (NWE-DO) | |
| 12/9/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/9/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/9/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/9/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/9/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/6/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | New England District Office (NWE-DO) |
| 12/5/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/5/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/5/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/5/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/5/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 8/15/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 341REGISTERED | New England District Office (NWE-DO) |
| 8/23/2011 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 7/14/2011 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 341REGISTERED | Detroit District Office (DET-DO) |
| 1/13/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/13/2005 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/13/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/13/2005 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/13/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/13/2005 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dectro International, Inc.'s FDA import refusal history?
Dectro International, Inc. (FEI: 3001446810) has 34 FDA import refusal record(s) in our database, spanning from 1/13/2005 to 4/3/2020.
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. Dectro International, Inc.'s FEI number is 3001446810.
What types of violations has Dectro International, Inc. received?
Dectro International, 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 Dectro International, Inc. come from?
All FDA import refusal data for Dectro International, 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.