New Spirit Naturals Inc.
⚠️ Moderate Risk
FEI: 3003815957 • San Dimas, CA • UNITED STATES
FEI Number
3003815957
Location
San Dimas, CA
Country
UNITED STATESAddress
615 W Allen Ave, , San Dimas, CA, 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
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2007 | 54ACH16VITAMIN E (TOCOPHEROL) | 482NUTRIT LBL | Los Angeles District Office (LOS-DO) |
| 3/12/2007 | 54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/12/2007 | 54FCH48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 3/12/2007 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/12/2007 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is New Spirit Naturals Inc.'s FDA import refusal history?
New Spirit Naturals Inc. (FEI: 3003815957) has 5 FDA import refusal record(s) in our database, spanning from 3/12/2007 to 3/12/2007.
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. New Spirit Naturals Inc.'s FEI number is 3003815957.
What types of violations has New Spirit Naturals Inc. received?
New Spirit Naturals Inc. 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 New Spirit Naturals Inc. come from?
All FDA import refusal data for New Spirit Naturals 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.