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MedMira Laboratories Inc.

⚠️ Moderate Risk

FEI: 3003595936 • Halifax, Nova Scotia • CANADA

FEI

FEI Number

3003595936

📍

Location

Halifax, Nova Scotia

🇨🇦

Country

CANADA
🏢

Address

Suite 1 Unit 1, 155 Chain Lake Dr, Halifax, Nova Scotia, Canada

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
12/30/2011
Latest Refusal
9/13/2011
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

2372×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

3411×

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).

Refusal History

DateProductViolationsDivision
12/30/2011
82MZFTEST, HIV DETECTION
237NO PMA
New Orleans District Office (NOL-DO)
10/27/2011
82MZFTEST, HIV DETECTION
237NO PMA
New Orleans District Office (NOL-DO)
9/13/2011
82MZFTEST, HIV DETECTION
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is MedMira Laboratories Inc.'s FDA import refusal history?

MedMira Laboratories Inc. (FEI: 3003595936) has 3 FDA import refusal record(s) in our database, spanning from 9/13/2011 to 12/30/2011.

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. MedMira Laboratories Inc.'s FEI number is 3003595936.

What types of violations has MedMira Laboratories Inc. received?

MedMira Laboratories Inc. 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 MedMira Laboratories Inc. come from?

All FDA import refusal data for MedMira Laboratories 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.