# FDA 483 - LifeSouth Community Blood Centers, Inc. - August 18, 2025

Source: https://www.keypedia.com/records/483/lifesouth-community-blood-centers-inc/c2c4704f-9554-4beb-ad4f-752b86bfa85d

> FDA 483 for LifeSouth Community Blood Centers, Inc. on August 18, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LifeSouth Community Blood Centers, Inc.
- Inspection Date: 2025-08-18
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: LifeSouth Community Blood Centers, Inc. in Gainesville, FL, was inspected by the FDA from August 12-18, 2025. The inspection revealed a significant issue concerning the firm's failure to adhere to manufacturer instructions for ABO blood grouping reagents. This included deficiencies in performing quality control testing and documenting reagent storage temperatures.

## Related Documents

- [483 - 2021-08-19](https://www.keypedia.com/records/483/lifesouth-community-blood-centers-inc/40662cbf-c7f7-4ee0-ad00-b2fd7b1e2fcd)
- [483 - 2021-08-19](https://www.keypedia.com/records/483/lifesouth-community-blood-centers-inc/2e957fd9-d776-4041-b14f-2a75e6a26245)
- [483 - 2025-08-18](https://www.keypedia.com/records/483/lifesouth-community-blood-centers-inc/707563bc-cd7d-484e-998f-dd2b82c1423f)

## Related Officers

- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

Company: https://www.keypedia.com/companies/lifesouth-community-blood-centers-inc/b1ddb4de-22e6-413a-a276-b3b8a3141c28

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6