QLT Inc.
⚠️ Moderate Risk
FEI: 3002888946 • Vancouver, BC • CANADA
FEI Number
3002888946
Location
Vancouver, BC
Country
CANADAAddress
520 West 6th Avenue, , Vancouver, BC, 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
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 |
|---|---|---|---|
| 7/22/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 6/21/2002 | 79GBACATHETER, BALLOON TYPE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 4/9/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 1/30/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is QLT Inc.'s FDA import refusal history?
QLT Inc. (FEI: 3002888946) has 4 FDA import refusal record(s) in our database, spanning from 1/30/2002 to 7/22/2002.
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. QLT Inc.'s FEI number is 3002888946.
What types of violations has QLT Inc. received?
QLT 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 QLT Inc. come from?
All FDA import refusal data for QLT 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.