OSI Optoelectronics Inc.October 18, 2023

FDA 483 - OSI Optoelectronics Inc. - October 18, 2023

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Record Details

OSI Optoelectronics Inc. in Hawthorne, CA, was inspected from October 11-18, 2023, and received one observation. The inspection revealed that the company failed to adequately document the results of design validation, specifically missing data sheets for DOLPHIN 2000 sensors, within its design history file. This indicates a deficiency in their design control and record-keeping practices for medical devices.

Company: OSI Optoelectronics Inc.
Inspection Date: October 18, 2023
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
People: Nancy Bogdanovic
Juanita Banuelos (investigator)

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ID · a1a59a81-2b23-4b35-b082-4fd768c0fd01