483
Biodex Medical Systems, Inc.Biodex Medical Systems, Inc. – FDA 483, Feb 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.
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ID · b8eb2107-f06d-4042-a833-60057417373b
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