# FDA 483 - Hamilton Thorne, Inc - November 09, 2023

Source: https://www.keypedia.com/records/483/hamilton-thorne-inc/f097c771-d5f6-4535-82da-851c5ce253ff

> FDA 483 for Hamilton Thorne, Inc on November 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hamilton Thorne, Inc
- Inspection Date: 2023-11-09
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Hamilton Thorne, Inc. in Beverly, MA, from November 6-9, 2023, identified significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and implement procedures for verifying CAPA effectiveness, addressing recurring training-related root causes, and adhering to established due dates for effectiveness checks. These issues indicate a breakdown in the firm's quality system regarding corrective and preventive actions.

## Related Officers

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

Company: https://www.keypedia.com/companies/hamilton-thorne-inc/854abcaa-4a0f-4537-8dee-53d6b696d840

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