# FDA 483 - Charles River Laboratories Ireland Ltd. - October 18, 2019

Source: https://www.keypedia.com/records/483/charles-river-laboratories-ireland-ltd/e9bad2ed-a0f0-4188-9644-d213e26bcf8a

> FDA 483 for Charles River Laboratories Ireland Ltd. on October 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories Ireland Ltd.
- Inspection Date: 2019-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Charles River Laboratories Ireland Ltd. in Ballina, Co. Mayo, a contract testing laboratory, revealed significant deficiencies in laboratory controls and equipment management. Observations included inadequate sterility testing procedures, lack of data integrity controls for computer systems and balances, and the use of uncalibrated pH meters for critical measurements. These issues indicate a failure to ensure drug product quality and data reliability.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/charles-river-laboratories-ireland-ltd/baf99307-f916-42f8-8707-410d236f27c3

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1