# FDA 483 - Charles River Laboratories Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/charles-river-laboratories-inc/8a76571c-a2a4-426e-b085-df016066dfba

> FDA 483 for Charles River Laboratories Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories Inc
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Charles River Laboratories, Inc. in Memphis, TN, revealed significant deficiencies in their operations. The firm's Quality Assurance oversight was found to be inadequate in managing deviations, investigations, and corrective actions in a timely manner. Additionally, environmental controls and manufacturing processes were insufficient to ensure product sterility, leading to microbial contamination, and raw material testing procedures were deficient.

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Company: https://www.globalkeysolutions.net/companies/charles-river-laboratories-inc/876b68d9-6285-4039-8732-05f876b5d911

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