1527806 Ontario Inc. o/a Accurex Health Care Mfg. Inc.
⚠️ High Risk
FEI: 3004886712 • Brantford, Ontario • CANADA
FEI Number
3004886712
Location
Brantford, Ontario
Country
CANADAAddress
20 Sage Crt, , Brantford, 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
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2015 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/16/2015 | 54YCY02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Division of Southeast Imports (DSEI) | |
| 4/18/2008 | 54HBH04FISH OIL (FATS AND LIPID SUBSTANCES) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54ABH13VITAMIN C (ASCORBIC ACID) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54ABA15VITAMIN D2 (CALCIFEROL) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54HBH04FISH OIL (FATS AND LIPID SUBSTANCES) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54HBH04FISH OIL (FATS AND LIPID SUBSTANCES) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54HBH03EVENING PRIMROSE OIL (FATS AND LIPID SUBSTANCES) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54ACE90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54HCH02BORAGE OIL (FATS AND LIPID SUBSTANCES) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54BCE01CALCIUM (MINERAL) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54ABH16VITAMIN E (TOCOPHEROL) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54ABE02VITAMIN B1 (THIAMINE) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54ACA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/18/2008 | 54HBH99FATS AND LIPID SUBSTANCES, N.E.C. | 308MFR INSAN | New York District Office (NYK-DO) |
Frequently Asked Questions
What is 1527806 Ontario Inc. o/a Accurex Health Care Mfg. Inc.'s FDA import refusal history?
1527806 Ontario Inc. o/a Accurex Health Care Mfg. Inc. (FEI: 3004886712) has 20 FDA import refusal record(s) in our database, spanning from 4/18/2008 to 1/21/2015.
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. 1527806 Ontario Inc. o/a Accurex Health Care Mfg. Inc.'s FEI number is 3004886712.
What types of violations has 1527806 Ontario Inc. o/a Accurex Health Care Mfg. Inc. received?
1527806 Ontario Inc. o/a Accurex Health Care Mfg. 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 1527806 Ontario Inc. o/a Accurex Health Care Mfg. Inc. come from?
All FDA import refusal data for 1527806 Ontario Inc. o/a Accurex Health Care Mfg. 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.