# FDA 483 - Command Medical Products LLC - November 30, 2018

Source: https://www.keypedia.com/records/483/command-medical-products-llc/5b415ecb-a7dc-4a78-a0cd-2360a1b1b460

> FDA 483 for Command Medical Products LLC on November 30, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Command Medical Products LLC
- Inspection Date: 2018-11-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Command Medical Products, Inc. in Ormond Beach, FL, received a Form FDA 483 with four observations related to their medical device manufacturing operations. The inspection revealed significant deficiencies in environmental control procedures for clean rooms, corrective and preventive action processes, complaint handling, and supplier control. Several issues were noted as repeat observations from a previous inspection, indicating persistent quality system failures.

## Related Documents

- [483 - 2023-08-08](https://www.keypedia.com/records/483/command-medical-products-llc/b0bad0f3-f35d-4ed5-a95a-de215a9e1e97)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)

Company: https://www.keypedia.com/companies/command-medical-products-llc/314b0685-1727-44a4-839c-9cb98ed96ea6

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6