Moore Spa Incorporated
⚠️ Moderate Risk
FEI: 3005818738 • Richmond, British Columbia • CANADA
FEI Number
3005818738
Location
Richmond, British Columbia
Country
CANADAAddress
7-13680 Bridgeport Rd, , Richmond, British Columbia, 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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2023 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | Division of Northern Border Imports (DNBI) | |
| 5/16/2014 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 11/7/2013 | 80LLKNON-INFLATABLE COMPRESSION LEGGING | Cincinnati District Office (CIN-DO) | |
| 11/7/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/7/2013 | 80LLKNON-INFLATABLE COMPRESSION LEGGING | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Moore Spa Incorporated's FDA import refusal history?
Moore Spa Incorporated (FEI: 3005818738) has 5 FDA import refusal record(s) in our database, spanning from 11/7/2013 to 7/31/2023.
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. Moore Spa Incorporated's FEI number is 3005818738.
What types of violations has Moore Spa Incorporated received?
Moore Spa Incorporated has been cited for 7 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 Moore Spa Incorporated come from?
All FDA import refusal data for Moore Spa Incorporated 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.