# Bleep, LLC – FDA 483, Aug 6, 2026

Source: https://www.keypedia.com/records/483/bleep-llc/4ffadbfd-7a82-4110-8f5c-880a8a3a4b68

> FDA 483 for Bleep, LLC on August 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bleep, LLC
- Inspection Date: 2026-08-06
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Bleep, LLC, a medical device manufacturer in Chapel Hill, NC, was cited for inadequate record-keeping related to risk management activities for a Class II medical device. The inspection revealed incomplete risk analysis worksheets and inconsistent hazard classifications, indicating a lack of thorough assessment. This suggests potential issues with the firm's quality system regarding product realization and risk control.

## Related Documents

- [483 - 2023-08-25](https://www.keypedia.com/records/483/bleep-llc/8d8bcd08-af31-46b4-b32e-a52ce7322144) — date: August 25, 2023

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7