# FDA 483 - Charles River Laboratories Inc - Unknown Date

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc/72c9cf33-56c3-4c2b-9f96-924e92584529

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

---

## Details

- Record Type: 483
- Company Name: Charles River Laboratories Inc
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Charles River Laboratories, Inc. in Memphis, TN, from October 13-17, 2025, identified a significant issue with the firm's documentation practices. Procedures for equipment cleaning, maintenance, and manufacturing training were not updated to accurately reflect current processes, equipment, and document numbers. This indicates a systemic problem with maintaining accurate and current operational documentation.

## Related Documents

- [EIR - 2018-02-15](https://www.keypedia.com/records/eir/charles-river-laboratories-inc/cc329ceb-3c59-4ad0-8aa8-82451c14833e)
- [483 - 2024-10-11](https://www.keypedia.com/records/483/charles-river-laboratories-inc/97c49f67-f4f5-4f09-bfc2-3e3d25eb14fd)
- [EIR - 2020-09-21](https://www.keypedia.com/records/eir/charles-river-laboratories-inc/fe4d7b04-a79b-4073-914f-ea25fbbe71f4)
- [483 - 2025-02-07](https://www.keypedia.com/records/483/charles-river-laboratories-inc/4ba4c9df-b72c-464b-a6ec-b29c74cc3d5f)
- [EIR - 2015-01-22](https://www.keypedia.com/records/eir/charles-river-laboratories-inc/8f670ae7-a0ef-47ca-ac03-483374c38620)

## Related Officers

- [Christine Harman](https://www.keypedia.com/people/christine-harman/916fa691-117d-446b-8b53-7413194e3eda)
- [Shaina R. Fullwood](https://www.keypedia.com/people/shaina-r-fullwood/4f056b90-a237-4c29-aa10-97cf3dc491a5)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4