# FDA 483 - Charles River Laboratories, Inc. - September 09, 2025

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc/4f272551-a9e3-424b-b5da-b0c943d78074

> FDA 483 for Charles River Laboratories, Inc. on September 09, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories, Inc.
- Inspection Date: 2025-09-09
- Product Type: other
- Office Name: New England District Office
- Summary: An FDA inspection of Charles River Laboratories, Inc. in Wilmington, MA, a contract testing laboratory, revealed a significant issue with the firm's investigation records. Specifically, written records for unexplained discrepancies did not consistently include complete conclusions and follow-up actions. This indicates a potential weakness in the firm's quality system regarding thoroughness of investigations and preventative measures.

## Related Documents

- [483 - 2017-06-21](https://www.keypedia.com/records/483/charles-river-laboratories-inc/40aa133a-6983-431b-b8da-5fd9b864ad5f)
- [483 - 2020-02-11](https://www.keypedia.com/records/483/charles-river-laboratories-inc/711c111b-a05d-4b0b-94f2-d0c76233324b)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/charles-river-laboratories-inc/3a0d2bc1-66b3-441b-9c7f-1f32a705b2ef

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144