AMICO PATIENT CARE CORPORATION

⚠️ Moderate Risk

FEI: 3012398026 • Richmond Hill, Ontario • CANADA

FEI

FEI Number

3012398026

📍

Location

Richmond Hill, Ontario

🇨🇦

Country

CANADA

🏢

Address

122 East Beaver Creek Rd, , Richmond Hill, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

31.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/12/2019

Latest Refusal

7/12/2013

Earliest Refusal

Score Breakdown

Violation Severity

30.0×40%

Refusal Volume

51.1×30%

Recency

0.0×20%

Frequency

38.9×10%

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

34123×

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
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
6/12/2019	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
11/2/2018	80KDPREGULATOR, VACUUM	341REGISTERED	Division of Southeast Imports (DSEI)
7/12/2013	89INWTABLE, MECHANICAL	341REGISTERED	Detroit District Office (DET-DO)

Frequently Asked Questions

What is AMICO PATIENT CARE CORPORATION's FDA import refusal history?

AMICO PATIENT CARE CORPORATION (FEI: 3012398026) has 23 FDA import refusal record(s) in our database, spanning from 7/12/2013 to 6/12/2019.

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. AMICO PATIENT CARE CORPORATION's FEI number is 3012398026.

What types of violations has AMICO PATIENT CARE CORPORATION received?

AMICO PATIENT CARE CORPORATION 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 AMICO PATIENT CARE CORPORATION come from?

All FDA import refusal data for AMICO PATIENT CARE CORPORATION 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.