Biodex Medical Systems, Inc.February 10, 2023

FDA 483 - Biodex Medical Systems, Inc. - February 10, 2023

Record Details

An FDA inspection of Biodex Medical Systems, Inc., a medical device manufacturer in Shirley, NY, revealed two observations related to inadequate record keeping. The firm failed to adequately maintain device history records, specifically regarding software versions for their S4 isokinetic Systems. Additionally, records of changes to Standard Operating Procedures were not adequately maintained.

Company: Biodex Medical Systems, Inc.
Inspection Date: February 10, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Kwong P. Lee (investigator)

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ID · b8eb2107-f06d-4042-a833-60057417373b