# FDA 483 - Charles River Laboratories, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/charles-river-laboratories-llc/f147493c-2487-46e1-9f8d-6f6a4ceef6a5

> FDA 483 for Charles River Laboratories, LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories, LLC
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Charles River Laboratories Skokie LLC was inspected regarding its clinical research operations. The inspection revealed significant issues with method validation, including inadequate determination of validation parameters for screening and confirmatory assays, and failures in assessing freeze-thaw and stability experiments. Additionally, the firm was cited for using inappropriate positive and negative controls and for improper titer assessment in subject samples.

## Related Documents

- [483 - 2019-07-26](https://www.keypedia.com/records/483/charles-river-laboratories-llc/e0375bd7-7a83-43ac-9268-c0d84806244c)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/amanda-e-lewin/7f30b6cb-52f1-4fc2-a8e5-90f037a4d73e)
- [Yiyue C. Zhang](https://www.keypedia.com/people/yiyue-c-zhang/bb9e053e-ff20-4724-b4dc-1ee2e8f23833)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd