Cogstate Inc.July 24, 2019

FDA 483 - Cogstate Inc. - July 24, 2019

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Record Details

Cogstate Healthcare LLC in New Haven, CT, was inspected from July 23-24, 2019, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's quality system, specifically regarding the establishment and execution of quality audit procedures and the frequency of management reviews. The firm lacked adequate documentation for both quality audits and management reviews conducted in 2017 and 2018.

Company: Cogstate Inc.
Inspection Date: July 24, 2019
Product Type: Drugs
Office: Division of Northeast Imports
Person: James P. Finn (investigator)

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