# FDA 483 - Bleep, LLC - August 25, 2023

Source: https://www.globalkeysolutions.net/records/483/bleep-llc/8d8bcd08-af31-46b4-b32e-a52ce7322144

> FDA 483 for Bleep, LLC on August 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bleep, LLC
- Inspection Date: 2023-08-25
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Bleep, LLC, a manufacturer of the Bleep DreamPort System in Chapel Hill, NC, received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in design change procedures, CAPA documentation, design plan establishment, supplier evaluation, and the organizational structure for quality system management, particularly concerning outsourced entities. These issues indicate a lack of robust quality system controls for medical device manufacturing.

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.globalkeysolutions.net/companies/bleep-llc/1be57339-b685-441e-a6de-3e720285163f

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