# FDA 483 - American Red Cross Blood Serv - August 15, 2019

Source: https://www.keypedia.com/records/483/american-red-cross-blood-serv/3d1e7fb9-7cad-498e-bd9b-bf61dd17a147

> FDA 483 for American Red Cross Blood Serv on August 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Red Cross Blood Serv
- Inspection Date: 2019-08-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The FDA inspected American Red Cross Blood Serv in Rochester, NY, from August 13-15, 2019, and issued a Form 483 with one observation. The inspection revealed that written standard operating procedures for collecting whole blood units were not consistently followed. Specifically, certain whole blood units were collected without the required mixer and were not immediately mixed after collection.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/american-red-cross-blood-serv/02956495-3173-4bae-a59d-2de6ae6e3ed2

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