Mountain High Organics, Inc
⚠️ Moderate Risk
FEI: 3002959422 • New Milford, CT • UNITED STATES
FEI Number
3002959422
Location
New Milford, CT
Country
UNITED STATESAddress
9 S Main St, , New Milford, CT, 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
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2006 | 24AFT51PEAS | 320LACKS FIRM | Detroit District Office (DET-DO) |
| 1/23/2006 | 24AFT99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | Detroit District Office (DET-DO) | |
| 1/23/2006 | 24AFT99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | Detroit District Office (DET-DO) | |
| 1/23/2006 | 23KFT08MILLET SEED (EDIBLE SEED) | Detroit District Office (DET-DO) | |
| 1/23/2006 | 24AFT51PEAS | Detroit District Office (DET-DO) | |
| 1/23/2006 | 24AGT51PEAS | 249FILTHY | Detroit District Office (DET-DO) |
| 1/23/2006 | 77LRKDEVICE, ANTI-SNORING | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Mountain High Organics, Inc's FDA import refusal history?
Mountain High Organics, Inc (FEI: 3002959422) has 7 FDA import refusal record(s) in our database, spanning from 1/23/2006 to 1/23/2006.
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. Mountain High Organics, Inc's FEI number is 3002959422.
What types of violations has Mountain High Organics, Inc received?
Mountain High Organics, Inc has been cited for 6 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 Mountain High Organics, Inc come from?
All FDA import refusal data for Mountain High Organics, 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.