Hain-Celestial Canada, ULC
⚠️ Moderate Risk
FEI: 3000097071 • Mississauga, Ontario • CANADA
FEI Number
3000097071
Location
Mississauga, Ontario
Country
CANADAAddress
5675 Keaton Cres, , Mississauga, 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 9/6/2013 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Detroit District Office (DET-DO) | |
| 9/6/2013 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Detroit District Office (DET-DO) | |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hain-Celestial Canada, ULC's FDA import refusal history?
Hain-Celestial Canada, ULC (FEI: 3000097071) has 7 FDA import refusal record(s) in our database, spanning from 3/12/2009 to 6/26/2020.
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. Hain-Celestial Canada, ULC's FEI number is 3000097071.
What types of violations has Hain-Celestial Canada, ULC received?
Hain-Celestial Canada, ULC has been cited for 3 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 Hain-Celestial Canada, ULC come from?
All FDA import refusal data for Hain-Celestial Canada, ULC 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.