AutoGenomics, Inc.December 4, 2019

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

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Record Details

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.

Company: AutoGenomics, Inc.
Inspection Date: December 4, 2019
Product Type: Other
Office: Division of Pharmaceutical Quality Operations IV
Person: Vicky L. Cruz (Investigator)

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