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AlphaProTech Inc

⚠️ Moderate Risk

FEI: 1000512204 • Valdosta, GA • UNITED STATES

FEI

FEI Number

1000512204

📍

Location

Valdosta, GA

🇺🇸
🏢

Address

323 S Blanchard St, , Valdosta, GA, United States

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
3/12/2009
Latest Refusal
3/12/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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
3/12/2009
79FXPCOVER, SHOE, OPERATING-ROOM
118NOT LISTED
New York District Office (NYK-DO)
3/12/2009
79FXXMASK, SURGICAL
118NOT LISTED
New York District Office (NYK-DO)
3/12/2009
79FXPCOVER, SHOE, OPERATING-ROOM
118NOT LISTED
New York District Office (NYK-DO)
3/12/2009
79FXXMASK, SURGICAL
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is AlphaProTech Inc's FDA import refusal history?

AlphaProTech Inc (FEI: 1000512204) has 4 FDA import refusal record(s) in our database, spanning from 3/12/2009 to 3/12/2009.

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. AlphaProTech Inc's FEI number is 1000512204.

What types of violations has AlphaProTech Inc received?

AlphaProTech 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 AlphaProTech Inc come from?

All FDA import refusal data for AlphaProTech 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.