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Maqa C.A.

⚠️ Moderate Risk

FEI: 3008463328 • Colinas Del Neveri • VENEZUELA

FEI

FEI Number

3008463328

📍

Location

Colinas Del Neveri

🇻🇪

Country

VENEZUELA
🏢

Address

Av Guzman Lander Lc3, , Colinas Del Neveri, , Venezuela

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/15/2010
Latest Refusal
9/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5083×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
9/15/2010
79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)
9/15/2010
75JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)
9/15/2010
80MEDSTERILANT, MEDICAL DEVICES
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Maqa C.A.'s FDA import refusal history?

Maqa C.A. (FEI: 3008463328) has 3 FDA import refusal record(s) in our database, spanning from 9/15/2010 to 9/15/2010.

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. Maqa C.A.'s FEI number is 3008463328.

What types of violations has Maqa C.A. received?

Maqa C.A. has been cited for 2 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 Maqa C.A. come from?

All FDA import refusal data for Maqa C.A. 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.