# FDA 483 - Charles River Laboratories Inc - August 25, 2023

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc/b56b53e9-5822-4c90-a349-94e94e2c35a0

> FDA 483 for Charles River Laboratories Inc on August 25, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories Inc
- Inspection Date: 2023-08-25
- 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 seven observations related to significant deficiencies in their manufacturing and quality control processes. Issues included failures to follow standard operating procedures, inadequate aseptic controls, deficient containment of contaminants, and poor facility maintenance leading to pest control problems. These findings indicate a lack of robust controls over critical operations, potentially impacting product quality and safety.

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## Related Officers

- [Hoda Abadeer](https://www.keypedia.com/people/hoda-abadeer/4ae6231f-1403-4d23-b551-e273a5de3c04)
- [Prajakta A. Varadkar](https://www.keypedia.com/people/prajakta-a-varadkar/93c01972-2e91-462e-8c2b-4a6520d3dd3f)
- [investigator](https://www.keypedia.com/people/wei-wang/943039ac-3917-4d32-9f58-1886c56aecdd)
- [Zhenzhen Ye](https://www.keypedia.com/people/zhenzhen-ye/a56d2d09-fbf3-4553-8c81-be3a372d76cb)
- [Jessica Chery](https://www.keypedia.com/people/jessica-chery/a7031c2d-307b-45b0-9078-0ce3f81dfc8a)

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

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