# FDA 483 - Intuitive Imaging Informatics LLC - August 06, 2021

Source: https://www.globalkeysolutions.net/records/483/intuitive-imaging-informatics-llc/714e5f73-3ec2-483b-b216-7f69e7ab2bc8

> FDA 483 for Intuitive Imaging Informatics LLC on August 06, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intuitive Imaging Informatics LLC
- Inspection Date: 2021-08-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Intuitive Imaging Informatics LLC, a medical device manufacturer in Bell Canyon, CA, identified two observations. The inspection found issues with the examination of device labeling for accuracy, specifically regarding the completeness of Unique Device Identifiers (UDI). Additionally, the firm failed to adequately document corrective and preventive action activities from a previous inspection.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/intuitive-imaging-informatics-llc/f9859746-3605-4161-9530-df423cf91653

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6