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Syntec Inc

⚠️ Moderate Risk

FEI: 3005254001 • Hillsboro, WI • UNITED STATES

FEI

FEI Number

3005254001

📍

Location

Hillsboro, WI

🇺🇸
🏢

Address

186 E Madison St, Po Box 369, Hillsboro, WI, United States

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/27/2012
Latest Refusal
2/27/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1862×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

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
2/27/2012
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
186INSANITARY
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/27/2012
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
186INSANITARY
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Syntec Inc's FDA import refusal history?

Syntec Inc (FEI: 3005254001) has 2 FDA import refusal record(s) in our database, spanning from 2/27/2012 to 2/27/2012.

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. Syntec Inc's FEI number is 3005254001.

What types of violations has Syntec Inc received?

Syntec Inc has been cited for 2 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 Syntec Inc come from?

All FDA import refusal data for Syntec 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.