Avaria Health & Beauty Corp.
⚠️ High Risk
FEI: 3014583374 • Cambridge, Ontario • CANADA
FEI Number
3014583374
Location
Cambridge, Ontario
Country
CANADAAddress
5-650 Jamieson Pky, , Cambridge, Ontario, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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 |
|---|---|---|---|
| 7/27/2023 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/10/2023 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/21/2023 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 10/18/2021 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Avaria Health & Beauty Corp.'s FDA import refusal history?
Avaria Health & Beauty Corp. (FEI: 3014583374) has 4 FDA import refusal record(s) in our database, spanning from 10/18/2021 to 7/27/2023.
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. Avaria Health & Beauty Corp.'s FEI number is 3014583374.
What types of violations has Avaria Health & Beauty Corp. received?
Avaria Health & Beauty Corp. 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 Avaria Health & Beauty Corp. come from?
All FDA import refusal data for Avaria Health & Beauty Corp. 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.