# FDA 483 - Philips Medical Systems (Cleveland) Inc - June 04, 2019

Source: https://www.keypedia.com/records/483/philips-medical-systems-cleveland-inc/dab2e952-8602-4b38-93d6-79f1c2ac3301

> FDA 483 for Philips Medical Systems (Cleveland) Inc on June 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Medical Systems (Cleveland) Inc
- Inspection Date: 2019-06-04
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Philips Medical Systems (Cleveland) Inc. in Cleveland, OH, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, complaint handling, and document control. These issues indicate a systemic failure to adequately manage and investigate product-related problems and ensure the integrity of quality records.

## Related Documents

- [483 - 2017-08-18](https://www.keypedia.com/records/483/philips-medical-systems-cleveland-inc/c0c8134f-048f-4c27-bd7c-faa25aaea07b)
- [483 - 2019-11-26](https://www.keypedia.com/records/483/philips-medical-systems-cleveland-inc/55e8811c-e7b7-42a5-ae18-08af6a7bf891)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)
- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/philips-medical-systems-cleveland-inc/f7e6009c-683b-4e1e-8268-0208083b1691

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22