MedAire, Inc.

⚠️ Moderate Risk

FEI: 3005798963 • Phoenix, AZ • UNITED STATES

FEI

FEI Number

3005798963

📍

Location

Phoenix, AZ

🇺🇸

Country

UNITED STATES

🏢

Address

23610 N 20th Dr Ste 10, , Phoenix, AZ, United States

Moderate Risk

FDA Import Risk Assessment

33.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/25/2008

Latest Refusal

10/23/2004

Earliest Refusal

Score Breakdown

Violation Severity

51.7×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

21.8×10%

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

Violation Summary

3414×

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).

5084×

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.

1182×

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).

1792×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

Date	Product	Violations	Division
6/25/2008	75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER	341REGISTERED	Florida District Office (FLA-DO)
6/25/2008	60XCA17ATENOLOL (ANTI-ADRENERGIC)	179AGR RX	Florida District Office (FLA-DO)
6/24/2008	81JBFGLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/24/2008	73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/24/2008	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
6/24/2008	56BDC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)	179AGR RX	Florida District Office (FLA-DO)
7/26/2006	79LRRKIT, FIRST AID	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
10/23/2004	79LRRKIT, FIRST AID	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is MedAire, Inc.'s FDA import refusal history?

MedAire, Inc. (FEI: 3005798963) has 8 FDA import refusal record(s) in our database, spanning from 10/23/2004 to 6/25/2008.

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. MedAire, Inc.'s FEI number is 3005798963.

What types of violations has MedAire, Inc. received?

MedAire, Inc. has been cited for 4 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 MedAire, Inc. come from?

All FDA import refusal data for MedAire, 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.