# FDA 483 - Charles River Laboratories, LLC - July 26, 2019

Source: https://www.keypedia.com/records/483/charles-river-laboratories-llc/e0375bd7-7a83-43ac-9268-c0d84806244c

> FDA 483 for Charles River Laboratories, LLC on July 26, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories, LLC
- Inspection Date: 2019-07-26
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Charles River Laboratories Ashland, LLC in Skokie, IL, a biopharmaceutics analytical facility, revealed two significant observations. The firm failed to include all valid data in statistical calculations for precision, accuracy, and total error during method validation. Additionally, the inspection found that the firm did not fully validate the precision and accuracy of certain dilution factors used in a study.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/charles-river-laboratories-llc/f147493c-2487-46e1-9f8d-6f6a4ceef6a5)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)
- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/charles-river-laboratories-llc/596ec0f9-2c59-4d36-bdf1-bdee2009dd1f

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669