# FDA 483 - Blood Connection, Inc. (The) - August 16, 2019

Source: https://www.keypedia.com/records/483/blood-connection-inc-the/64a485a0-c684-4c88-86d8-29389012846d

> FDA 483 for Blood Connection, Inc. (The) on August 16, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blood Connection, Inc. (The)
- Inspection Date: 2019-08-16
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: The Blood Connection, Inc. in Raleigh, NC, a blood bank, was inspected from August 14-16, 2019, and cited for a significant deficiency related to computer system validation. The firm failed to maintain proper written records and validation data for its blood establishment computer software. This indicates a serious lapse in data integrity and quality system controls.

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## Related Officers

- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/blood-connection-inc-the/c049c660-43f3-4747-9f5c-4e62d8c5a92d

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7