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Mack Molding Company, Inc

⚠️ Moderate Risk

FEI: 1000086912 • Arlington, VT • UNITED STATES

FEI

FEI Number

1000086912

📍

Location

Arlington, VT

🇺🇸
🏢

Address

608 Warm Brook Rd, , Arlington, VT, United States

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/26/2012
Latest Refusal
1/26/2012
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

DateProductViolationsDivision
1/26/2012
73DQAOXIMETER
2380NO PMA/PDP
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Mack Molding Company, Inc's FDA import refusal history?

Mack Molding Company, Inc (FEI: 1000086912) has 1 FDA import refusal record(s) in our database, spanning from 1/26/2012 to 1/26/2012.

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. Mack Molding Company, Inc's FEI number is 1000086912.

What types of violations has Mack Molding Company, Inc received?

Mack Molding Company, Inc 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 Mack Molding Company, Inc come from?

All FDA import refusal data for Mack Molding Company, 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.