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Medicraft Inc

⚠️ Moderate Risk

FEI: 3011030106 • Atlanta, GA • UNITED STATES

FEI

FEI Number

3011030106

📍

Location

Atlanta, GA

🇺🇸
🏢

Address

3284 Northside Pkwy NW, , Atlanta, GA, United States

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

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

Statistics

19
Total Refusals
1
Unique Violations
2/18/2016
Latest Refusal
2/11/2016
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
48.2×30%
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

11819×

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)

Frequently Asked Questions

What is Medicraft Inc's FDA import refusal history?

Medicraft Inc (FEI: 3011030106) has 19 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. Medicraft Inc's FEI number is 3011030106.

What types of violations has Medicraft Inc received?

Medicraft 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 Medicraft Inc come from?

All FDA import refusal data for Medicraft 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.