# FDA 483 - Focus Medical, LLC - May 02, 2025

Source: https://www.globalkeysolutions.net/records/483/focus-medical-llc/f088a85b-ddf2-415e-8136-0134b0b18e60

> FDA 483 for Focus Medical, LLC on May 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Focus Medical, LLC
- Inspection Date: 2025-05-02
- Product Type: device
- Office Name: New England District Office
- Summary: Focus Medical, LLC, a medical device manufacturer in Bethel, CT, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies primarily related to process controls, device history records, labeling, calibration procedures, and complaint investigations for their CO2 and other laser systems. These issues indicate a lack of adherence to quality system regulations for medical devices.

## 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/focus-medical-llc/dc3869e7-ddde-4fb3-bf78-b606df8ae023

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