Company

United States

ACI Medical LLC, San Marcos, CA – FDA Inspections

Inspection records and compliance data for ACI Medical LLC in San Marcos, California. 3 FDA inspections on record, 1 Form 483, last inspected April 24, 2026.

Company Profile

This profile covers ACI Medical LLC based in San Marcos, California, United States.

FDA Inspection History

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

First inspected July 16, 2013. Last inspected April 24, 2026.

Most cited issue areas

DHR - UDI not included1 inspection
DMR - not or inadequately maintained1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
April 24, 2026	Not classified	Medical Devices & Rad Health	1319316
August 17, 2023	VAI	Medical Devices & Rad Health · Compliance: Devices	1215085
July 16, 2013	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	840350

FDA documents

Form 483s (1)

Form 483s · August 17, 2023

People (1)

Kelvin Cheung

Person

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