# FDA 483 - American National Red Cross (The) - October 21, 2019

Source: https://www.keypedia.com/records/483/american-national-red-cross-the/e3a4b34e-3b0f-4244-bebf-08792d9cf5c1

> FDA 483 for American National Red Cross (The) on October 21, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American National Red Cross (The)
- Inspection Date: 2019-10-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The American National Red Cross in Pleasant Hill, CA, a blood donor center, was cited for failing to establish indelible records documenting temperature controls during the inspection. Specifically, the firm did not record pre-conditioning start times for temperature-sensitive units as required by their SOPs, relying instead on erasable white boards. This indicates a significant lapse in maintaining proper documentation for critical process parameters.

## Related Officers

- [investigator](https://www.keypedia.com/people/seyyida-saterfield/6e7569f6-4f95-40d1-9707-6a6c530bfe13)

Company: https://www.keypedia.com/companies/american-national-red-cross-the/3ea4cccf-ade9-4d35-b656-3e1f377ccdaa

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b