# FDA 483 - LifeSouth Community Blood Centers, Inc. - August 19, 2021

Source: https://www.globalkeysolutions.net/records/483/lifesouth-community-blood-centers-inc/40662cbf-c7f7-4ee0-ad00-b2fd7b1e2fcd

> FDA 483 for LifeSouth Community Blood Centers, Inc. on August 19, 2021. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LifeSouth Community Blood Centers, Inc.
- Inspection Date: 2021-08-19
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of LifeSouth Community Blood Centers, Inc. in Gainesville, FL, identified one observation. The firm failed to maintain proper temperature control for Red Blood Cells during shipment, specifically regarding apheresis concurrent Red Blood Cells not being stored on ice as required by SOPs for certain units. This issue could impact the quality and safety of the blood products.

## Related Documents

- [483 - 2025-08-18](https://www.globalkeysolutions.net/records/483/lifesouth-community-blood-centers-inc/707563bc-cd7d-484e-998f-dd2b82c1423f)

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Investigator](https://www.globalkeysolutions.net/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

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

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