# FDA 483 - Charles River Laboratories Inc - February 07, 2025

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc/4ba4c9df-b72c-464b-a6ec-b29c74cc3d5f

> FDA 483 for Charles River Laboratories Inc on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories Inc
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Charles River Laboratories Inc. in Memphis, TN, a cell therapy manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in employee training, master production records, aseptic process validation, facility maintenance, and inventory control for raw materials and finished products. These issues indicate a lack of adequate controls to ensure the quality and sterility of drug products.

## Related Documents

- [483 - 2023-08-25](https://www.keypedia.com/records/483/charles-river-laboratories-inc/b56b53e9-5822-4c90-a349-94e94e2c35a0)
- [483 - 2024-10-11](https://www.keypedia.com/records/483/charles-river-laboratories-inc/97c49f67-f4f5-4f09-bfc2-3e3d25eb14fd)
- [483 - Unknown Date](https://www.keypedia.com/records/483/charles-river-laboratories-inc/8a76571c-a2a4-426e-b085-df016066dfba)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)

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

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea