# FDA 483 - Ochsner Health System  Blood Bank - March 31, 2022

Source: https://www.globalkeysolutions.net/records/483/ochsner-health-system-blood-bank/31d0ee10-fa83-4974-8fe5-1687dd7176dc

> FDA 483 for Ochsner Health System  Blood Bank on March 31, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ochsner Health System  Blood Bank
- Inspection Date: 2022-03-31
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Ochsner Health System Blood Bank in New Orleans, LA, revealed three significant observations. The firm failed to consistently follow written standard operating procedures for blood and blood component processing, including a specific instance of not conducting platelet quality control. Additionally, the inspection noted a failure to provide adequate privacy for donor suitability interviews, which was a repeat observation, and a failure to use supplies according to manufacturer instructions during donor arm preparation.

## Related Officers

- [Juanisha H Palmer](https://www.globalkeysolutions.net/people/juanisha-h-palmer/07aa903d-a6a7-4693-9957-9f09ff542dba)
- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)

Company: https://www.globalkeysolutions.net/companies/ochsner-health-system-blood-bank/a773b46b-d0c1-4642-ad7e-20f25b3ba5f5

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea