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FTZ 177A

⚠️ Moderate Risk

FEI: 3012044188 • Mount Vernon, IN • UNITED STATES

FEI

FEI Number

3012044188

📍

Location

Mount Vernon, IN

🇺🇸
🏢

Address

4601 Highway 62 E, , Mount Vernon, IN, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/18/2016
Latest Refusal
2/18/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

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.

Refusal History

DateProductViolationsDivision
2/18/2016
61PCS99ANTI-DIABETIC N.E.C.
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is FTZ 177A's FDA import refusal history?

FTZ 177A (FEI: 3012044188) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2016 to 2/18/2016.

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. FTZ 177A's FEI number is 3012044188.

What types of violations has FTZ 177A received?

FTZ 177A has been cited for 1 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 FTZ 177A come from?

All FDA import refusal data for FTZ 177A 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.