# FDA 483 - Cogstate Inc. - July 24, 2019

Source: https://www.keypedia.com/records/483/cogstate-inc/4d2387a9-c058-4452-835b-9839d9be0d0d

> FDA 483 for Cogstate Inc. on July 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cogstate Inc.
- Inspection Date: 2019-07-24
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/cogstate-inc/1bc4eac6-2369-444c-b05e-d287527dbaef

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94