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Medin Corp

⚠️ Moderate Risk

FEI: 2246425 • Passaic, NJ • UNITED STATES

FEI

FEI Number

2246425

📍

Location

Passaic, NJ

🇺🇸
🏢

Address

90 Dayton Ave Ste 7D, , Passaic, NJ, United States

Moderate Risk

FDA Import Risk Assessment

45.1
LowModerateHighCritical

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

Statistics

22
Total Refusals
1
Unique Violations
2/18/2016
Latest Refusal
2/11/2016
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
50.4×30%
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

11822×

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
2/18/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Atlanta District Office (ATL-DO)
2/18/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Atlanta District Office (ATL-DO)
2/18/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Atlanta District Office (ATL-DO)
2/18/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Atlanta District Office (ATL-DO)
2/18/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Atlanta District Office (ATL-DO)
2/18/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Atlanta District Office (ATL-DO)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)
2/11/2016
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Medin Corp's FDA import refusal history?

Medin Corp (FEI: 2246425) has 22 FDA import refusal record(s) in our database, spanning from 2/11/2016 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. Medin Corp's FEI number is 2246425.

What types of violations has Medin Corp received?

Medin Corp 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 Medin Corp come from?

All FDA import refusal data for Medin Corp 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.