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

Source: https://www.globalkeysolutions.net/records/483/biodex-medical-systems-inc/b8eb2107-f06d-4042-a833-60057417373b

> FDA 483 for Biodex Medical Systems, Inc. on February 10, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biodex Medical Systems, Inc.
- Inspection Date: 2023-02-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/biodex-medical-systems-inc/436949c2-cd7a-4818-8f55-0f99e731ff60

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961