# FDA 483 - Steris PLC - November 06, 2023

Source: https://www.globalkeysolutions.net/records/483/steris-plc/42d0c823-d250-4ac1-a99b-ebc70b7ef0e7

> FDA 483 for Steris PLC on November 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steris PLC
- Inspection Date: 2023-11-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Steris PLC, a human drug manufacturer in St. Louis, MO, was cited for significant deficiencies in its quality system related to Septihol Hand Sanitizer. Observations include the absence of a written stability testing program, failure to conduct timely annual product reviews, and a lack of adequate written procedures for production and process controls. These issues indicate a systemic breakdown in ensuring product quality, purity, and strength, particularly concerning contract manufacturing oversight and product distribution conditions.

## Related Officers

- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.globalkeysolutions.net/companies/steris-plc/88ffc827-5fc2-41cd-b708-02b96911d97d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8