O3UV, LLC - Inspection Records

Inspection records and compliance data for O3UV, LLC in Grand Ledge, Michigan. 1 FDA inspection on record (1 OAI), 1 Form 483, 1 warning letter, last inspected August 31, 2023.

Company Profile

This profile covers O3UV, LLC based in Grand Ledge, Michigan, United States.

FDA Inspection History

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

Inspected August 31, 2023.

Most cited issue areas

Design control - no procedures1 inspection
Lack of or inadequate complaint procedures1 inspection
Lack of or inadequate DHR procedures1 inspection

Most recent inspections

Date	Classification	Office	Project area
August 31, 2023	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices

Documents (2)

WARNING_LETTER - O3UV, LLC - 2023-08-31

WARNING_LETTER

FDA Inspection 1216506 - O3UV, LLC - 2023-08-31

fda_inspection

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