# FDA 483 - Photonicare Inc - August 25, 2023

Source: https://www.globalkeysolutions.net/records/483/photonicare-inc/994efe98-f9c7-40a5-9cfa-a2369d231d99

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

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## Details

- Record Type: 483
- Company Name: Photonicare Inc
- Inspection Date: 2023-08-25
- Product Type: device
- Office Name: Chicago District Office
- Summary: Photonicare Inc, a medical device manufacturer in Champaign, IL, received a Form FDA 483 citing three observations related to its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, including issues with CAPA effectiveness verification and software updates. Additionally, the firm's design change procedures lacked defined categories, and management failed to ensure the quality policy was understood by employees and contained misleading information.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/photonicare-inc/8e8ccf3f-bade-4243-aa3c-99f02032453a

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