# FDA 483 - Arnot Ogden Medical Center - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/arnot-ogden-medical-center/af1bbfb0-d655-4ad1-bf39-a45b16980f2a

> FDA 483 for Arnot Ogden Medical Center on August 14, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arnot Ogden Medical Center
- Inspection Date: 2019-08-14
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Arnot Ogden Medical Center's Hospital Blood Bank revealed significant deficiencies in their quality system. Observations included a lack of written standard operating procedures for investigating product deviations, inadequate equipment maintenance and calibration practices, and incomplete records for transfusion reaction investigations. These issues indicate a need for improved adherence to regulatory requirements for blood and blood component processing.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/cara-minelli/23ac8da5-9b62-4be6-a258-54fab84fa646)

Company: https://www.globalkeysolutions.net/companies/arnot-ogden-medical-center/8ca01dd3-0af5-4ee5-adba-40547f78f539

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961