FITNESS FACTORY
⚠️ Moderate Risk
FEI: 3021934090 • Liverpool • UNITED KINGDOM
FEI Number
3021934090
Location
Liverpool
Country
UNITED KINGDOMAddress
212 Century Building To, , Liverpool, , United Kingdom
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).
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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 |
|---|---|---|---|
| 3/7/2023 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 3/7/2023 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 3/7/2023 | 66VIF99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/7/2023 | 66VIF99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FITNESS FACTORY's FDA import refusal history?
FITNESS FACTORY (FEI: 3021934090) has 4 FDA import refusal record(s) in our database, spanning from 3/7/2023 to 3/7/2023.
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. FITNESS FACTORY's FEI number is 3021934090.
What types of violations has FITNESS FACTORY received?
FITNESS FACTORY 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 FITNESS FACTORY come from?
All FDA import refusal data for FITNESS FACTORY 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.