# FDA 483 - Bridge to Life Ltd - September 21, 2023

Source: https://www.globalkeysolutions.net/records/483/bridge-to-life-ltd/69087a75-2e21-4817-bc4f-749bb471d65b

> FDA 483 for Bridge to Life Ltd on September 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bridge to Life Ltd
- Inspection Date: 2023-09-21
- Product Type: device
- Office Name: Chicago District Office
- Summary: Bridge to Life Ltd, a specification developer in Northbrook, IL, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed failures in complaint handling, including inadequate investigation and documentation of device-related complaints and MDR reportability. Additionally, the firm failed to conduct required internal quality audits and management reviews as established in its own procedures.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/bridge-to-life-ltd/596b2602-382a-41c6-a3fe-032a9481748c

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669