# FDA 483 - Charles River Laboratories, Inc. - January 04, 2024

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc/5b02bea3-c2b2-41c6-aa99-91d90f3f4e5e

> FDA 483 for Charles River Laboratories, Inc. on January 04, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Charles River Laboratories, Inc.
- Inspection Date: 2024-01-04
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Charles River Laboratories, Inc. in Malvern, PA, a control testing laboratory, revealed significant deficiencies in their quality control systems. The firm failed to establish adequate written procedures for production and process controls, as their environmental monitoring system repeatedly missed critical deviations in cleanrooms and biological safety cabinets. Furthermore, investigations into these discrepancies were found to be inadequate, lacking thoroughness in addressing system failures and assessing product impact.

## Related Documents

- [EIR - 2010-05-14](https://www.keypedia.com/records/eir/charles-river-laboratories-inc/377327f1-bd8c-448d-9813-9fed8a9640c0)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/charles-river-laboratories-inc/b007c718-aa18-4f77-84ea-4d96765ed0e6

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8