# FDA 483 - We are Blood - October 07, 2019

Source: https://www.globalkeysolutions.net/records/483/we-are-blood/6a7ef9e2-f8b7-4d7d-8d6b-b935b2708da8

> FDA 483 for We are Blood on October 07, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: We are Blood
- Inspection Date: 2019-10-07
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of We Are Blood, a blood donor center in Round Rock, TX, identified a significant procedural deviation. The firm failed to consistently follow its written standard operating procedures for vital signs and physical examinations during the collection of blood and blood components. Specifically, staff did not adhere to the SOP when a donor's temperature failed to register twice, leading to an unauthorized third attempt.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)

Company: https://www.globalkeysolutions.net/companies/we-are-blood/b4a179d8-a1a6-4225-ba47-cefb7b82be6f

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9