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All Terrain Co

⚠️ Moderate Risk

FEI: 3005074387 • Sunapee, NH • UNITED STATES

FEI

FEI Number

3005074387

📍

Location

Sunapee, NH

🇺🇸
🏢

Address

Po Box 840, , Sunapee, NH, United States

Moderate Risk

FDA Import Risk Assessment

46.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

18
Total Refusals
3
Unique Violations
2/16/2010
Latest Refusal
2/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
55.5×40%
Refusal Volume
47.4×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11818×

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).

162×

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.

752×

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

DateProductViolationsDivision
2/16/2010
65LBL99PROTECTANT N.E.C.
118NOT LISTED
16DIRECTIONS
75UNAPPROVED
New York District Office (NYK-DO)
2/16/2010
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
75UNAPPROVED
New York District Office (NYK-DO)
2/16/2010
79OHOFIRST AID KIT WITHOUT DRUG
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
79LRRKIT, FIRST AID
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
64ABK99DISINFECTANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
2/16/2010
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is All Terrain Co's FDA import refusal history?

All Terrain Co (FEI: 3005074387) has 18 FDA import refusal record(s) in our database, spanning from 2/16/2010 to 2/16/2010.

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. All Terrain Co's FEI number is 3005074387.

What types of violations has All Terrain Co received?

All Terrain Co 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 All Terrain Co come from?

All FDA import refusal data for All Terrain Co 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.