# FDA EIR - CHARLES RIVER LABORATORIES - August 03, 2018

Source: https://www.keypedia.com/records/eir/charles-river-laboratories/33ac91c0-6b69-45f2-9a9a-4bc158f4ca67

> FDA EIR for CHARLES RIVER LABORATORIES on August 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: CHARLES RIVER LABORATORIES
- Inspection Date: 2018-08-03
- Product Type: drugs
- Office Name: Division of New Drug Bioequivalence Evaluation
- Summary: An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Charles River Laboratories Ashland LLC from July 23 to August 3, 2018. This inspection, operating under Compliance Program 7348.808, aimed to ensure compliance with regulations for nonclinical laboratory studies. While no FDA Form 483 was issued, several observations were discussed with management. Key issues included one undocumented protocol deviation and five instances of non-compliance with Standard Operating Procedures (SOPs) associated with study protocols. Specific concerns involved identified dosing errors in a final study report, inaccurate documentation regarding serviced water systems, improper storage of inventory in the general receiving area, and inadequate labeling of large ice containers in chemistry areas. Additionally, SOP non-compliance was noted for not documenting exposure times during a specific examination phase of a study. Management was highly cooperative, took immediate corrective actions, and committed to formally responding to all discussed items.

## Related Documents

- [EIR - 2018-08-03](https://www.keypedia.com/records/eir/charles-river-laboratories/a270b968-8fda-4859-9de9-0ad1834480e2)
- [EIR - 2021-07-16](https://www.keypedia.com/records/eir/charles-river-laboratories/6aa307ab-edb2-48d2-9a8d-fdb4abe9fdbb)

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-cooper/4813e60d-c8da-4df2-bc48-ecfb06a55cf8)
- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.keypedia.com/companies/charles-river-laboratories/079ae978-a3c8-4c11-a1dc-3f036f3f6df0

Office: https://www.keypedia.com/offices/division-of-new-drug-bioequivalence-evaluation/7d1832a1-fe08-4f30-bc30-d3e9ed74f264