Aztex Enterprises Ltd.
⚠️ Moderate Risk
FEI: 3003516782 • Burlington, Ontario • CANADA
FEI Number
3003516782
Location
Burlington, Ontario
Country
CANADAAddress
925 Century Dr, , Burlington, Ontario, 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
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).
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 |
|---|---|---|---|
| 11/30/2023 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/23/2023 | 64ABY99DISINFECTANT N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/24/2023 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/24/2023 | 53LI06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/6/2021 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/9/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2010 | 64AAK99DISINFECTANT N.E.C. | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Aztex Enterprises Ltd.'s FDA import refusal history?
Aztex Enterprises Ltd. (FEI: 3003516782) has 7 FDA import refusal record(s) in our database, spanning from 2/5/2010 to 11/30/2023.
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. Aztex Enterprises Ltd.'s FEI number is 3003516782.
What types of violations has Aztex Enterprises Ltd. received?
Aztex Enterprises Ltd. 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 Aztex Enterprises Ltd. come from?
All FDA import refusal data for Aztex Enterprises Ltd. 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.