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Parker Medical Systems Division Merillville

✅ Low Risk

FEI: 1000115297 • Merrillville, IN • UNITED STATES

FEI

FEI Number

1000115297

📍

Location

Merrillville, IN

🇺🇸
🏢

Address

1201 E 86th Pl, , Merrillville, IN, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
10/31/2007
Latest Refusal
10/31/2007
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

Refusal History

DateProductViolationsDivision
10/31/2007
80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Parker Medical Systems Division Merillville's FDA import refusal history?

Parker Medical Systems Division Merillville (FEI: 1000115297) has 1 FDA import refusal record(s) in our database, spanning from 10/31/2007 to 10/31/2007.

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. Parker Medical Systems Division Merillville's FEI number is 1000115297.

What types of violations has Parker Medical Systems Division Merillville received?

Parker Medical Systems Division Merillville 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 Parker Medical Systems Division Merillville come from?

All FDA import refusal data for Parker Medical Systems Division Merillville 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.