Xenex Laboratories Inc.
⚠️ Moderate Risk
FEI: 3007170694 • Coquitlam, British Columbia • CANADA
FEI Number
3007170694
Location
Coquitlam, British Columbia
Country
CANADAAddress
2440 Canoe Ave Unit 102, , Coquitlam, British Columbia, 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).
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 |
|---|---|---|---|
| 7/2/2025 | 62MBJ08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/5/2011 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/5/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 62GCB41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 65JCS31PROGESTERONE (PROGESTIN) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 62CAY41MINOXIDIL (ANTI-HYPERTENSIVE) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 56JIS22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 64LAS38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 8/29/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 3/22/2006 | 60GRS01DISULFIRAM (ALCOHOL DETERRENT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Xenex Laboratories Inc.'s FDA import refusal history?
Xenex Laboratories Inc. (FEI: 3007170694) has 11 FDA import refusal record(s) in our database, spanning from 3/22/2006 to 7/2/2025.
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. Xenex Laboratories Inc.'s FEI number is 3007170694.
What types of violations has Xenex Laboratories Inc. received?
Xenex Laboratories Inc. has been cited for 2 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 Xenex Laboratories Inc. come from?
All FDA import refusal data for Xenex Laboratories 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.