Fidelitone Inc.
⚠️ Moderate Risk
FEI: 3005490390 • Elizabethton, TN • UNITED STATES
FEI Number
3005490390
Location
Elizabethton, TN
Country
UNITED STATESAddress
100 Fidelitone Way, , Elizabethton, TN, United States
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
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).
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2019 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2019 | 54FYY43DAMIANA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2015 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/27/2011 | 54YDA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 54YDA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 10/20/2010 | 54ECZ99HERBALS & BOTANICAL TEAS, N.E.C. | 11UNSAFE COL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fidelitone Inc.'s FDA import refusal history?
Fidelitone Inc. (FEI: 3005490390) has 6 FDA import refusal record(s) in our database, spanning from 10/20/2010 to 3/15/2019.
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. Fidelitone Inc.'s FEI number is 3005490390.
What types of violations has Fidelitone Inc. received?
Fidelitone 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 Fidelitone Inc. come from?
All FDA import refusal data for Fidelitone 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.