# FDA 483 - Defibtech, LLC - March 25, 2025

Source: https://www.globalkeysolutions.net/records/483/defibtech-llc/b6f57b32-55b3-4acb-a60f-12c782f75de9

> FDA 483 for Defibtech, LLC on March 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Defibtech, LLC
- Inspection Date: 2025-03-25
- Product Type: device
- Office Name: New England District Office
- Summary: Defibtech, LLC, a medical device manufacturer in Branford, CT, was cited with five observations during an FDA inspection for significant quality system deficiencies. These issues include failures in UDI submission, complaint handling, corrective and preventive actions, control of nonconforming product, and supplier management for its Automated Chest Compressors. The findings indicate a systemic lack of established and followed procedures across several critical areas of device manufacturing and quality control.

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/defibtech-llc/4ebf10b2-dd7d-449a-979b-c65820d96663

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144