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

Source: https://www.keypedia.com/records/eir/charles-river-laboratories/a270b968-8fda-4859-9de9-0ad1834480e2

> 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: Cincinnati District Office
- Summary: An FDA Good Laboratory Practice (GLP) surveillance inspection of Charles River Laboratories Ashland LLC was conducted from July 23 to August 3, 2018. This inspection, requested by the Division of New Drug Bioequivalence Evaluation and the Office of Study Integrity and Surveillance, aimed to ensure compliance with the regulatory framework governing nonclinical laboratory studies. While no FDA Form 483, Inspectional Observations, was issued, several discussion items were raised.

Main issues included one undocumented protocol deviation and five instances of Standard Operating Procedure (SOP) non-compliance across various protocols. Specific examples involved inadequate documentation of anesthesia times, missing details in animal disposition records, incomplete room cleaning logs, and insufficient information on necropsy notification forms. Additionally, dosing errors were found in a final study report, water system service locations were inaccurately documented, inventory in the receiving area was improperly stored, and large ice containers lacked proper labeling.

Management at Charles River Laboratories Ashland LLC was cooperative and took immediate action to address and correct all identified issues during the inspection. They committed to formally responding to these discussion items. The previous inspection's observations were reviewed and found not to be an issue during this current inspection.

## Related Documents

- [EIR - 2018-08-03](https://www.keypedia.com/records/eir/charles-river-laboratories/33ac91c0-6b69-45f2-9a9a-4bc158f4ca67)
- [EIR - 2021-07-16](https://www.keypedia.com/records/eir/charles-river-laboratories/6aa307ab-edb2-48d2-9a8d-fdb4abe9fdbb)

## Related Officers

- [company_representative](https://www.keypedia.com/people/jennifer-starkey/2532f1c6-b41f-4855-b523-477d07d81ad0)
- [company_representative](https://www.keypedia.com/people/jelynn-stinson/3f77ab85-7804-4151-b02a-48998fde5860)
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Company: https://www.keypedia.com/companies/charles-river-laboratories/079ae978-a3c8-4c11-a1dc-3f036f3f6df0

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22