# FDA 483 - AutoGenomics, Inc. - December 04, 2019

Source: https://www.globalkeysolutions.net/records/483/autogenomics-inc/9b796b40-648f-4266-a815-20ab6d04b9ec

> FDA 483 for AutoGenomics, Inc. on December 04, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AutoGenomics, Inc.
- Inspection Date: 2019-12-04
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Autogenomics, Inc. in Carlsbad, CA, was inspected by the FDA from December 2-4, 2019. The inspection revealed deficiencies in the firm's procedures for ensuring purchased products and services meet specified requirements, particularly concerning the re-evaluation and documentation of supplier qualifications. This indicates a lapse in quality system controls related to external suppliers.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/vicky-l-cruz/282da571-56be-48f4-96c6-d590829b12c2)

Company: https://www.globalkeysolutions.net/companies/autogenomics-inc/27387d90-2794-4b47-91ac-9351cb3d618b

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