Paladin Labs Inc
⚠️ Moderate Risk
FEI: 3003265951 • Montreal, QC • CANADA
FEI Number
3003265951
Location
Montreal, QC
Country
CANADAAddress
6111 Ave Royalmount, , Montreal, QC, 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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2012 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 9/28/2012 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 9/14/2012 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 9/9/2009 | 64GCA29LEVONORGESTREL (ESTROGEN) | Detroit District Office (DET-DO) | |
| 8/24/2007 | 78MRESOLUTION, SODIUM HYALURONATE | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Paladin Labs Inc's FDA import refusal history?
Paladin Labs Inc (FEI: 3003265951) has 5 FDA import refusal record(s) in our database, spanning from 8/24/2007 to 9/28/2012.
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. Paladin Labs Inc's FEI number is 3003265951.
What types of violations has Paladin Labs Inc received?
Paladin Labs Inc has been cited for 5 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 Paladin Labs Inc come from?
All FDA import refusal data for Paladin Labs 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.