Epicare Acquisitions, Llc - Inspection Records

Inspection records and compliance data for Epicare Acquisitions, Llc in Lawrenceville, New Jersey. 3 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected January 12, 2026.

Company Profile

This profile covers Epicare Acquisitions, Llc based in Lawrenceville, New Jersey, United States.

FDA Inspection History

FDA inspections: 3
OAI: 1
VAI: 0
NAI: 1
Unclassified: 1
Form 483s: 2
Warning letters: 1

First inspected February 10, 2022. Last inspected January 12, 2026.

Most cited issue areas

Lack of or inadequate procedures2 inspections
Design validation- Lack of or inadequate procedures1 inspection
Devices subject to device identification GUDID data submission requirements.1 inspection

Most recent inspections

Date	Classification	Office	Project area
January 12, 2026	Not classified	New Jersey District Office	Compliance: Medical Devices
December 13, 2024	OAI	New Jersey District Office	Postmarket Assurance: Medical Devices
February 10, 2022	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act

Documents (12)

FDA Inspection 1298218 - Epicare Acquisitions, Llc - 2026-01-12

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483 - Epicare Acquisitions, Llc - 2024-12-13

483

WARNING_LETTER - Epicare Acquisitions, Llc - 2024-12-13

WARNING_LETTER

FDA Inspection 1256450 - Epicare Acquisitions, Llc - 2024-12-13

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FDA Inspection 1256450 - Epicare Acquisitions, Llc - 2024-12-13

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FDA Inspection 1256450 - Epicare Acquisitions, Llc - 2024-12-13

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FDA Inspection 1256450 - Epicare Acquisitions, Llc - 2024-12-13

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FDA Inspection 1256450 - Epicare Acquisitions, Llc - 2024-12-13

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FDA Inspection 1256450 - Epicare Acquisitions, Llc - 2024-12-13

fda_inspection

483 - Epicare Acquisitions, Llc - 2022-02-10

483

FDA Inspection 1161983 - Epicare Acquisitions, Llc - 2022-02-10

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FDA Inspection 1161983 - Epicare Acquisitions, Llc - 2022-02-10

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... and 2 more documents

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Epicare Acquisitions, Llc - Inspection Records

Inspection records and compliance data for Epicare Acquisitions, Llc in Lawrenceville, New Jersey. 3 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected January 12, 2026.

Company Profile

This profile covers Epicare Acquisitions, Llc based in Lawrenceville, New Jersey, United States.

FDA Inspection History

FDA inspections: 3
OAI: 1
VAI: 0
NAI: 1
Unclassified: 1
Form 483s: 2
Warning letters: 1

First inspected February 10, 2022. Last inspected January 12, 2026.

Most cited issue areas

Lack of or inadequate procedures2 inspections
Design validation- Lack of or inadequate procedures1 inspection
Devices subject to device identification GUDID data submission requirements.1 inspection

Most recent inspections

Date	Classification	Office	Project area
January 12, 2026	Not classified	New Jersey District Office	Compliance: Medical Devices
December 13, 2024	OAI	New Jersey District Office	Postmarket Assurance: Medical Devices
February 10, 2022	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act