# FDA 483 - Analogic Corporation - August 25, 2022

Source: https://www.keypedia.com/records/483/analogic-corporation/9f763be6-0aca-436e-9e88-c821fdcda99f

> FDA 483 for Analogic Corporation on August 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Analogic Corporation
- Inspection Date: 2022-08-25
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Analogic Corporation in Peabody, MA, a manufacturer of computed tomography systems, revealed a significant issue with device history records. Specifically, four device history records for CTXX85 systems, including units distributed for human and veterinary use, did not include the required primary identification label. This indicates a failure to manufacture devices in accordance with regulatory requirements.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/analogic-corporation/e833b34e-cb3b-4b19-ac2f-8ae91b12d33f

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