Hunter Amenities International Limited
⚠️ Moderate Risk
FEI: 3002951228 • Burlington, Ontario • CANADA
FEI Number
3002951228
Location
Burlington, Ontario
Country
CANADAAddress
1205 Corporate 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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 3/19/2021 | 62HAL99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/22/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/3/2015 | 62FAL07CETYLPYRIDINIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | Detroit District Office (DET-DO) | |
| 10/24/2005 | 53BC99OTHER BATH PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 53BC99OTHER BATH PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 1/3/2002 | 53MY01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/3/2002 | 53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/3/2002 | 53MY01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hunter Amenities International Limited's FDA import refusal history?
Hunter Amenities International Limited (FEI: 3002951228) has 8 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 3/19/2021.
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. Hunter Amenities International Limited's FEI number is 3002951228.
What types of violations has Hunter Amenities International Limited received?
Hunter Amenities International Limited 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 Hunter Amenities International Limited come from?
All FDA import refusal data for Hunter Amenities International Limited 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.