483
Charles River Laboratories, LLCCharles River Laboratories, LLC – FDA 483
Record Details
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.
- Product type
- drugs
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ID · f147493c-2487-46e1-9f8d-6f6a4ceef6a5
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