Clario Inc.

⚠️ Moderate Risk

FEI: 1000103389 • Philadelphia, PA • UNITED STATES

FEI

FEI Number

1000103389

📍

Location

Philadelphia, PA

🇺🇸

Country

UNITED STATES

🏢

Address

1818 Market St Ste 2600, , Philadelphia, PA, United States

Moderate Risk

FDA Import Risk Assessment

33.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/5/2014

Latest Refusal

9/8/2005

Earliest Refusal

Score Breakdown

Violation Severity

54.4×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

8.9×10%

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

1188×

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).

5087×

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.

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).

Refusal History

Date	Product	Violations	Division
9/5/2014	74DPSELECTROCARDIOGRAPH	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
2/3/2011	74DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE	118NOT LISTED 341REGISTERED 508NO 510(K)	Chicago District Office (CHI-DO)
7/22/2006	74DPSELECTROCARDIOGRAPH	118NOT LISTED 341REGISTERED 508NO 510(K)	San Francisco District Office (SAN-DO)
3/28/2006	74DRXELECTRODE, ELECTROCARDIOGRAPH	118NOT LISTED	New York District Office (NYK-DO)
2/21/2006	74DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
12/16/2005	74DQDSTETHOSCOPE, ELECTRONIC	118NOT LISTED 341REGISTERED 508NO 510(K)	San Francisco District Office (SAN-DO)
9/22/2005	74LOSSYSTEM, ECG ANALYSIS,	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
9/8/2005	74DPSELECTROCARDIOGRAPH	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Clario Inc.'s FDA import refusal history?

Clario Inc. (FEI: 1000103389) has 8 FDA import refusal record(s) in our database, spanning from 9/8/2005 to 9/5/2014.

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. Clario Inc.'s FEI number is 1000103389.

What types of violations has Clario Inc. received?

Clario Inc. has been cited for 3 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 Clario Inc. come from?

All FDA import refusal data for Clario 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.