483
AutoGenomics, Inc.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.
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ID · 9b796b40-648f-4266-a815-20ab6d04b9ec