# FDA 483 - OcuMetrics, Inc. - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/ocumetrics-inc/9b795e1f-04cb-410c-8f9f-0f34b0b6fc44

> FDA 483 for OcuMetrics, Inc. on December 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OcuMetrics, Inc.
- Inspection Date: 2019-12-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: GenMetrics, Inc. in Mountain View, CA, was inspected by the FDA, resulting in four observations primarily concerning deficiencies in their quality system. The inspection revealed significant issues with corrective and preventive actions (CAPA) procedures and documentation, including repeat observations from previous inspections. Additionally, the firm lacked adequate control over suppliers and had not established proper procedures for changes to existing procedures.

## Related Officers

- [Amogh Pathi](https://www.globalkeysolutions.net/people/amogh-pathi/1325ce17-ca08-4cfb-818e-37889eccb31b)
- [investigator](https://www.globalkeysolutions.net/people/eric-j-heinze/f16828ab-f1e0-4556-bccc-700d93965b86)

Company: https://www.globalkeysolutions.net/companies/ocumetrics-inc/a293f272-b12c-428f-b92c-9d4422e54155

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b