# FDA 483 - Microgenics Corporation - December 15, 2016

Source: https://www.globalkeysolutions.net/records/483/microgenics-corporation/356b7688-3796-45e6-8bbb-fbf9215e5e65

> FDA 483 for Microgenics Corporation on December 15, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microgenics Corporation
- Inspection Date: 2016-12-15
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Microgenics Corporation, a manufacturer in Fremont, CA, was inspected by the FDA, resulting in one observation. The firm failed to adequately document corrective and preventive action activities, specifically closing a CAPA without fully investigating the root cause of nonconformities in their DRI Salicylate Serum Tox Assay. This indicates a deficiency in their quality system regarding CAPA procedures.

## Related Officers

- [Sara M. Richardson](https://www.globalkeysolutions.net/people/sara-m-richardson/460de568-e9ad-49bd-bf63-291bea7731db)
- [Investigator](https://www.globalkeysolutions.net/people/james-a-lane/f6cd3d8d-7de9-45c5-9380-7e0c5de4720e)

Company: https://www.globalkeysolutions.net/companies/microgenics-corporation/afa7631f-c7cb-467d-8c9b-c3f4cc83cc65

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