# FDA 483 - Charles River Laboratories Inc. - March 15, 2024

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc/e7446b3b-10b7-4ce9-88ca-41e63f79c856

> FDA 483 for Charles River Laboratories Inc. on March 15, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories Inc.
- Inspection Date: 2024-03-15
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: Charles River Laboratories Inc. received an FDA Form 483 following an inspection conducted from March 11 to March 15, 2024, at its nonclinical laboratory in Horsham, PA. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified two significant observations regarding the conduct and reporting of nonclinical laboratory studies.The first observation noted deficiencies in final study reports, which lacked complete descriptions of methods used. Specifically, two studies failed to include actual environmental conditions, such as animal room temperature and humidity, over the study period. Furthermore, the frequency of dose preparation was not adequately identified in one study's materials and methods section.The second observation highlighted that the study director failed to ensure unforeseen circumstances affecting study quality and integrity were documented, assessed, and reported. For one particular study, animal room temperatures were consistently below the minimum range for extended periods, but the impact of this protocol deviation was neither evaluated nor included in the final report.Charles River Laboratories Inc. is expected to promptly address these findings to ensure adherence to regulatory standards for the conduct and reporting of nonclinical laboratory studies, emphasizing thorough documentation and assessment of all study-related events.

## Related Officers

- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)
- [investigator](https://www.keypedia.com/people/gabrielle-j-swain/55f33430-41dc-4fae-bac0-ec6ea340feb6)
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Company: https://www.keypedia.com/companies/charles-river-laboratories-inc/e546c072-ea16-4c46-bfce-a48575560910

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8